DECREE NUMBER 4725 OF 2005 (26th December)

Whereby the sanitary registries regime, marketing permission, and sanitary

surveillance of the medical devices for human use are regulated.

The President of the Republic of Colombia in the exercise of the legal and
constitutional powers, especially the ones conferred by the numeral 11 of Article 189 of
the Political Constitution, the Article 564 of the 9th Law of 1979, the Article 245 of the
100th Law of 1993 and the numeral 42.3 of Article 42 of the 715th Law of 2001,

DECREES

CHAPTER I

General dispositions
Article 1°. Application purpose and scope. This decree’s purpose is to regulate the
health records regime, marketing permission, and sanitary surveillance related to the
production, processing, packaging, storage, sales, usage, importation, exportation,
marketing, and maintenance of medical devices for human use, for which compliance
will be mandatory to all natural or legal individuals who dedicate to the mentioned
activities in the national territory.
Paragraph. Custom-made and in vitro diagnostic reagents medical devices are
excepted from compliance with the provisions of the present decree.
Article 2°. Definitions. For application purposes of the present decree, the following
definitions are adopted:
Accessory. The one especially intended by the manufacturer to be used in conjunction
with a medical device, so that the medical device can be used in accordance with the
purpose intended by its manufacturer.
Conditioning. All operations whereby a device medical is packed and labeled for its
distribution.
Caveat. A call of attention that is generally included in the labels and/or packaging texts
about some particular risk associated with the use of medical devices.
Good Manufacturing Practices for Medical Devices, BPM: The procedures and methods
used to ensure quality during the manufacture, packaging, storage, and installation of
medical devices for human use. These procedures refer to the organizational structure,
responsibilities, processes, and resources to implement the quality requirements
associated with the medical device.
Storage and Conditioning Capacity Certificate, CCAA. Administrative act issued by the
Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima, which states
compliance with the sanitary conditions for storage and/or conditioning, quality control,
endowment, and human resources of medical devices importers, guaranteeing proper
functioning thereof, as well as their technical capacity and quality.
Certificate of Compliance with Good Manufacturing Practices, CCBPM. Administrative act
issued by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima, for
manufacturers of medical devices wherein it is stated that the manufacturing
establishment complies with the Good Manufacturing Practices for Medical Devices
issued by the Ministry of Social Protection.
Technical Concept of Sanitary Conditions. It is the document issued by the Instituto
Nacional de Vigilancia de Medicamentos y Alimentos, Invima, wherein compliance with
the hygienic, technical, locative, endowment, human resources, and quality control
conditions are stated to guarantee the proper functioning of the manufacturing
establishment, as well as the technical capacity and quality of the products therein made
and which will rule until Compliance with Good Manufacturing Practices for Medical
Devices, BPM is certified.
Active Medical Device. Any medical device whose operation depends on a source of
electrical energy or any source of energy different than that one directly generated by
the human body or by gravity, and which acts by converting said energy. Sanitary
products intended to transmit energy, substances, or other elements without significant
modification from an active medical device to the patient, will not be considered active
medical devices.
Therapeutic Active Medical Device. Any active medical device used only in combination
with other medical devices intended to hold, modify, replace, or restore biological functions
or structures in the context of treating or relieving a disease, injury, or deficiency.
Altered Medical Device. It is the one immersed in any of the following situations:
a) When without fulfilling the requirements indicated in this decree, the medical device
had been replaced, totally or partially subtracted, or had the constituent elements that
are part of its composition or the officially approved design replaced, or when
substances or elements that can modify its effects, or its physicochemical and
microbiological functional characteristics had been added;
a) When without fulfilling the requirements indicated in this decree, the medical device
had suffered transformations in its functional, physicochemical, biological, and
microbiological characteristics due to chemical, physical or biological agents;
b) When applicable, in case the expiration date corresponding to the useful life of the
medical device is expired;
c) When it does not correspond to the authorized by the health authority or the original
had been totally or partially replaced;
d) When it is not stored or preserved with due precautions because of its nature;
e) When the original design or composition of the medical device is altered.
Combined Medical Device. Considered to be a combined medical device when it forms,
along with a drug, a single product intended to be used exclusively in this combination.
If its main function has a pharmacological action, it will be evaluated under the Decree
677 provisions of 1995 or the regulations that modify, add or replace it. If the main
function is to be a device and the medicine is accessorial, it will be ruled by the
provisions of the present decree with the medicine's quality and safety verification.
Medical Device Intended for Clinical Research. Any medical device to be used by a
specialist physician in investigations performed in an appropriate human clinical
environment.
Fraudulent Medical Device. The one that is marketed without complying with the
requirements of the technical and legal provisions that regulate it or that is manufactured,
totally or partially assembled in Colombia without the respective health registration or
marketing permit.
Implantable Medical Device. Any medical device designed to be totally implanted in the
human body or to replace an epithelial surface or the ocular surface through surgical
intervention and intended to remain there for a period of not less than thirty (30) days
after the intervention.
Invasive Medical Device. The one which partially or completely penetrates inside the
body, either through a body orifice or through the body surface.
Surgical-type Invasive Medical Device. An invasive medical device that penetrates the
body's interior through the body surface by means of surgical intervention.
For the purposes of the present decree, medical devices other than those referred to in
this definition and whose penetration does not occur through one of the recognized
body orifices will be considered invasive surgical products.
Reusable Surgical Medical Device. An instrument with surgical purposes intended for
cutting, drilling, closing, scarifying, scraping, clamping, retracting, trimming, or other similar
procedures, without being connected to any active medical device and which may be reused
after all relevant procedures have been performed.
Medical Device for Human Use. Any instrument, device, machine, software, biomedical
equipment, or another similar or related item used by itself or in combination, including
components, parts, accessories, and informatics programs proposed by the
manufacturer for correctly applying it, to be used in:
Disease diagnosis, prevention, monitoring, treatment, or alleviation;
b) Injury or deficiency diagnosis, prevention, monitoring, treatment, alleviation, or
compensation;
c) Research, substitution, modification, or support of the anatomical structure or a
physiological process;
d) Pregnancy diagnosis and conception control;
e) Pregnancy care, childbirth or after it, including newborn's care;
f) Products for disinfection and/or sterilization of medical devices.
Medical devices for human use must not exert the desired main action by
pharmacological, immunological, or metabolic means.
Unavailable Medical Device or Vital Biomedical Equipment. Those essential and
irreplaceable to safeguard life or alleviate a patient or group of patients suffering, and
that due to low commercialization profitability conditions ain't available or in non-
sufficient quantity in the country.
Devices With Contact Surface. Those that include contact with skin, mucous
membrane, and open or compromised surfaces.
Internal and External Communication Devices. Includes devices that come into direct
contact with the bloodstream or blood, body fluids, or those that communicate with
tissues, bones, and the pulp/dentin system.
Finished Medical Device. The one found in its final packaging, that is suitable for being
used and ready for commercial distribution
Custom-made Medical Device. Devices specifically manufactured by following the written
prescription of a health professional and to be used by a certain patient.
Biomedical Equipment. Operational and functional medical devices that bring together
electrical, electronic, or hydraulic systems and subsystems, including the computer
programs that intervene in its proper functioning and that are intended by the
manufacturer to be used in human beings for the purposes of prevention, diagnosis,
treatment or rehabilitation. Those medical devices implanted in the human being or
those destined for single-use do not constitute biomedical equipment.
Controlled Technology Biomedical Equipment. Those medical devices that are subject
to special control for being included in any of the following situations:
a) According to their high-risk classification and the vulnerability degree associated with
these devices; as well as those derived from the design, manufacture, installation,
handling, and intended destination;
b) The prototypes that lead to new scientific and technological developments;
c) Those that are subject to supply control through the use of standards that allow the
efficient distribution of technology by geographical areas in the country according to the
parameters of Article 65 of the 715 th Law of 2001.
d) That correspond to used or repowered equipment;
e) That require an investment of more than 700 current legal minimum salaries for their
acquisition, installation, and use, are classified as IIb and III in accordance with the
provisions of the present decree and are under the parameters of Article 65 of the 715th Law
of 2001.
The Ministry of Social Protection through an administrative act may classify as
controlled technology biomedical equipment, in addition to those set forth in the present
article, the equipment of classes I and IIa provided for the present decree when the
needs of the Sector so require.
New Biomedical Equipment. Equipment that has not been used and is not more than two
(2) years old from the date of manufacture.
Demonstration Biomedical Equipment. New biomedical equipment that is used to
promote the technology.
Imported biomedical demonstration equipment can be nationalized under the terms and
conditions established in the customs regulations for the temporary import modality and
can only be certified by its manufacturer or its representative in Colombia.
Used Biomedical Equipment. Includes all equipment that has been used for providing
services and/or in demonstration processes, which do not have more than five (5) years
of service from manufacture or assembly.
Repowered Biomedical Equipment. Includes all the equipment that has been used for
providing health services or in demonstration processes, and that has had part of its
main subsystems replaced with new parts by the manufacturer or the repowerer
authorized by the manufacturer, meeting the thereof specified requirements and the
safety standards it was built under.
Prototype Biomedical Equipment. Includes all those equipment found in the
experimentation phase that have not yet been used for providing services or in
demonstrations, and that haven't got the free sale certificate issued by the competent
national body or its counterpart in the origin country.
Stability. The medical device's capacity to maintain its original characteristics during its useful
life within the established quality specifications.
Clinical study. Any research performed on human beings with the intention of discovering or
verifying the clinical effects or any other effect of medical devices and/or identifying any
adverse reaction, in order to prove safeness and/or effectiveness thereof.
Label. All printed, written or graphic information attached that comes with the medical
device.
Manufacturer. The natural or legal person responsible for the design, manufacture,
packaging, conditioning, and labeling of a medical device.
The manufacturer will be responsible for the final product regardless of whether the
aforementioned steps are carried out by the same person or by a third party on their
behalf.
Expiration Date. It indicates the maximum time wherein the quality specifications
established for a product's use are guaranteed.
Intended Purpose. The use for which the medical device is intended according to the
indications provided by the manufacturer on the labeling, the usage instructions, and/or
advertising material that must be following those authorized in the respective health
registry or the marketing permit.
Biomedical Equipment Short-term Temporary Import. The one performed when the
biomedical equipment is imported to serve a specific purpose that determinates its short
stay in the country. The maximum import period will be six (6) months from the release
of the merchandise, extendable by the customs authority for three (3) more months.
Biomedical Equipment Long-term Temporary Import. The one performed in the case
the biomedical is equipment considered as a capital good, the parts and accessories
necessary for its normal operation that come in the same shipment. The maximum time
period of this importation will be five (5) years counted from the release of the
merchandise.
Adverse incident. Harm or potential risk of unintentional harm to the patient, operator,
or the environment that occurs as a consequence of using a medical device.
Insert. Any printed, digitized or graphic material that contains instructions for the safe
storage, use, or consumption of the medical device.
Batch. A defined quantity of raw material, packaging material, or processed product in
a single process or a series of processes, in such a way that it can be expected to be
homogeneous. In the case of a continuous manufacturing process, the batch must
correspond to a defined fraction of the production, characterized by the homogeneity
sought in the medical device. The lot can be subdivided.
Model. Designation by numbers, letters, or their combination for identifying the design
and composition of biomedical equipment.
Batch or serial number. Designation (by numbers, letters, or both) of the batch or series
of medical devices that allows locating and reviewing all the manufacturing and
inspection operations performed during their production as well as their traceability, in
case it is necessary.
Marketing Permit for Controlled Technology Biomedical Equipment. Public document
issued by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima,
prior to the procedure aimed to verify compliance with the technical-legal requirements
established in the present decree, which empowers a natural or legal person to produce,
market, import, export, assemble, process, sell or market controlled biomedical
equipment.
Precautions. Safety measures that must be followed when using any medical device.
Reference. Qualitative or design variant of a product, used for the same use and
corresponding to the same owner and manufacturers.
Health Register. Public document issued by the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, prior to the procedure of verifying compliance with
the technical-legal and health requirements established in the present decree, which
empowers a natural or legal person to produce, market, import, export, pack, process,
sell and/or store a medical device.
Safety. Medical device characteristic that allows its use without greater possibilities of
causing adverse effects.
Semi-elaborate. Any manufacturing process that allows obtaining a medical device up
to its container or packaging.
Technical support service. All the performed for ensuring the proper functioning of
biomedical equipment, involving those considered as preventive and corrective
maintenance and calibration verification, among others.
Central Nervous System. For the purposes of the present decree, the central nervous
system is understood to be the brain, the spinal cord, and the meninges.
Central Circulatory System. It corresponds to the following vessels: pulmonary artery,
ascending aorta, coronary arteries, common carotid artery, external and internal carotid
arteries, cerebral arteries, brachiocephalic trunk, venae cordis (major coronary and coronary
sinus), pulmonary vein, superior and inferior venae cavae.
Implant Card. Document where the medical device's name, model, batch or serial number,
and manufacturer's address are recorded, as well as for the institution's name and the date
whereby implantation was performed, and the patient's identification.
Technovigilance. Set of activities that aim to identify and qualify serious and unwanted
adverse effects produced by medical devices, as well as for identifying risk factors
associated with these effects or characteristics, based on the notification, registration,
and systematic evaluation of a medical device's adverse effects so their frequency,
severity, and incidence can be determined in order to prevent their appearance.
Short-term use. Normally intended to be used continuously for a period of up to thirty
(30) days.
Prolonged use. Normally intended to be used continuously for a period of more than
thirty (30) days.
Temporary use. Normally intended to be used continuously for less than sixty (60)
minutes.
Article 3°. Technical studies. In the development of the 9th numeral of Article 4 and Article
21 of Decree 1290 of 1994, or the rule that modifies, adds, or replaces it, the Instituto
Nacional de Vigilancia de Medicamentos y Alimentos, Invima, may carry out the technical
studies and the necessary analytical checks of medical devices and controlled technology
biomedical equipment in order to verify their quality conditions through a public or private
entity.
The power referred to in the preceding paragraph will be exercised without prejudice to
the fact that the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima,
may resume the function of directly performing the technical studies and the necessary
analytical checks of the medical devices and controlled technology biomedical
equipment.
Article 4°. Fundamental Requirements for Medical Devices' Safety and
Performance. Medical devices must comply with the safety and performance
requirements established by the manufacturer that apply to them in accordance with
the intended purpose.
When selecting the most appropriate solutions to the derivated risks from the use of
medical devices, the manufacturer will apply the following requirements in the order
indicated below:
a) Eliminate or reduce risks as far as possible (inherent safety in design and
manufacturing);
b) Adopt the appropriate protection measures, including alarms against risks that
cannot be eliminated in case it is necessary;
c) Inform users of the residual risks due to the incomplete effectiveness of the
protection measures adopted.
Paragraph 1°. The medical devices contemplated in the present decree must be
marketed, designed, manufactured, and stored in such a way that their use does not
compromise the clinical condition, health, or safety of patients or those who are in
contact with them when they are used under the intended conditions and purposes.
Medical devices must offer the indications attributed to them by the manufacturer,
meaning that they must be designed and manufactured in such a way that they can
perform their functions as specified by the manufacturer.
Paragraph 2°. During the validity period provided by the manufacturer, the safety and
operation principles of medical devices must not be altered to such an extent that the
clinical status, health, and safety of patients and third parties are compromised, when
the product is brought under the situations that may arise from normal usage conditions.
CHAPTER II
Classification of medical devices
Article 5. Classification. The medical devices classification issued by the manufacturer
is formulated on the potential risks related to usage and possible failure of the devices,
based on the combination of several criteria such as duration of body contact, invasion
degree, and local effect against the systemic effect.
The classification of medical devices must be set up following the rules established in
article 7 of this decree, within the following classes:
Class I. Low-risk medical devices subject to general controls, not intended to protect or
sustain life or for a special importance use in preventing the deterioration of human
health, and that do not represent an unreasonable potential risk of illness or injury.
Class IIa. Moderate-risk medical devices subject to special controls in the
manufacturing phase to demonstrate their safety and effectiveness.
Class llb. High-risk medical devices subject to special controls in design and
manufacturing to demonstrate their safety and effectiveness.
Class III. Very high-risk medical devices subject to special controls, intended to protect
or sustain life or for use of substantial importance in preventing the deterioration of
human health, or if their use presents a potential risk of illness or injury
Article 6. Classification criteria. The classification normativity application will be ruled
by the intended purpose of the medical devices:
a) If a medical device is intended to be used in combination with another medical device,
the classification rules will apply to each product separately from the product they are
used along with;
b) The informatics supports that work for operating a product or that have an influence
on its use will be automatically included in the same category;
c) If a medical device is not intended to be used exclusively or mainly in a specific part
of the body, its most critical specific use will be considered for classification;
d) If several rules are applicable to the same medical device, taking into account the
functions attributed to it by the manufacturer, the rules that lead to the highest
classification shall apply.
Article 7. Classification rules. The following rules will be taken into account for classifying
a medical device:
A. NON-INVASIVE MEDICAL DEVICES
Rule 1. All non-invasive medical devices will be included in class I unless some of the
following rules apply to them
Rule 2. All non-invasive medical devices intended for the conduction or storage of blood,
body fluids or tissues, liquids or gases intended for perfusion, administration, or introduction
into the body, will be part of class IIa; as long as:
a) They can be connected to a class IIa or higher class active medical device;
b) They are intended to be used for the storage or channeling of blood or other fluids, or
for the storage of organs, parts of organs, or body tissues.
In all other cases, they will be included in class I.
Rule 3. All non-invasive medical devices intended to modify the biological or chemical
composition of blood, other body fluids or other liquids intended to be introduced into
the body will be included in class IIb, except if the treatment consists of filtration,
centrifugation, or exchanges of gases or heat, in which case they will be included in
class IIa.
Rule 4. All non-invasive medical devices that come into contact with injured skin will be
classified as:
a) Class I if they are intended to be used as a mechanical barrier for compression or for
the absorption of exudates;
b) Class IIb if they are mainly intended to be used with wounds that have produced a
rupture of the dermis and can only heal by secondary intention;
c) Class IIa in all other cases, including medical devices primarily intended to act in the
microenvironment of a wound;
B. INVASIVE MEDICAL DEVICES
Rule 5. All invasive medical devices in relation to body orifices, except surgical-type invasive
medical devices that are not intended to be connected to an active medical device, will be
included in:
a) Class I if they are intended for temporary use;
b) Class IIa if they are intended for short-term use, except if they are used in the oral
cavity up to the pharynx, in the external auditory canal up to the eardrum, or in a nasal
cavity, in which case they will be included in Class I;
c) Class IIb if they are intended for prolonged use, except if they are used in the oral cavity
up to the pharynx, in the external auditory canal up to the eardrum, or in a nasal cavity
and cannot be absorbed by the mucous membrane, in which case they will be included
in class IIa.
d) All invasive products concerning body orifices, except surgical-type invasive products
which are intended to connect to an active product of class IIa or higher, will be included
in class IIa.
Rule 6. All surgical-type invasive medical devices intended for temporary use will be
included in class IIa, unless that:
a) They are reusable surgical instruments, in which case they will be included in class
I;
b) They are intended to supply energy in the form of ionizing radiation, in which case
they will be included in class IIb;
c) They are intended to exert a biological effect or to be totally or largely absorbed, in
which case they will be included in class IIb;
d) They are intended for the administration of medicine through a supply system if this is
done in a potentially dangerous way, taking into account the application mode, in which
case they will be included in class IIb;
e) Are specifically intended to diagnose, monitor, or correct a cardiac or central circulatory
system disorder by direct contact with these body parts, in which case they will be included
in class III.
Rule 7. All surgical-type invasive medical devices intended for short-term use will be
included in class IIa, unless their purpose is:
a) To supply energy in the form of ionizing radiation, in which case they will be included
in class IIb;
b) To experience chemical modifications in the body, except if the products are placed
inside the teeth, or administering medications, in which case they will be included in
class IIb;
c) To specifically diagnose, monitor, or correct a cardiac or central circulatory system
disorder by having direct contact with these parts of the body, in which case they will
be included in class III;
d) To be used specifically in direct contact with the central nervous system, in which
case they will be included in class III;
e) To exert a biological effect or to be absorbed, totally or in large part, in which case
they will be included in class III.
Rule 8. All implantable medical devices and long-term surgical invasive medical devices
will be included in class IIb unless they are intended for:
a) Being placed inside the teeth, in which case, they will be included in class IIa;
b) Being used in direct contact with the heart, the central circulatory system, or the
central nervous system, in which case they will be included in class III;
c) Exerting a biological effect or being totally or largely absorbed, in which case they
will be included in class III;
d) Suffering chemical modifications in the body, except if the products are placed inside
the teeth, or for medications administration, in which case they will be included in class
III;
C. ADDITIONAL RULES APPLICABLE TO ACTIVE MEDICAL DEVICES
Rule 9. All active therapeutic medical devices intended to administer or exchange energy
will be included in class IIa, except if their characteristics are such that they can administer
energy to the human body or exchange it with it in a potentially dangerous way, taking into
account the nature, density, and point of application of the energy, in which case they will
be included in class IIb.
All active medical devices intended to control the operation of class IIb active therapeutic
products, or intended to directly influence the operation of those products will be included in
class IIb.
Rule 10. All active medical devices for diagnostic purposes will be included in class IIa,
as long as:
a) They are intended to supply energy that will be absorbed by the human body, in
which case products whose function is to illuminate the patient's body in the visible
spectrum are excluded;
b) They are intended to create an image of in vivo distribution of radioactive drugs;
c) They are intended to allow direct vital physiological processes diagnosis or
monitoring unless they are specifically intended to monitor vital physiological
parameters when there are variations in those parameters, for example, variations in
cardiac function, breathing, and central nervous system activity, may pose an
immediate danger to the patient's life, in which case they will be included in class IIb.
d) Active medical devices intended to emit ionizing radiation and that are intended for
radiology with diagnostic and therapeutic purposes, including products to control or
monitor thereof, or that directly influence their operation will be included in class IIb.
Rule 11. Active medical devices intended to administer medications, body fluids, or other
substances to the body or to extract them from it, will be included in class IIa unless these
procedures are done in a potentially dangerous way, taking into account the nature of the
substances, the body part in question and the application method, in which case they will
be included in class IIb.
Rule 12. All other active medical devices will be included in class I.
A. SPECIAL RULES
Rule 13. All medical devices that incorporate as an integral part a substance that, if
used independently could be considered a medicine and that can exert an accessory
action on the human body to the medical devices one, will be included in class III.
Rule 14. All medical devices used for contraceptive purposes or for preventing the
transmission of sexual contact transmissible diseases will be considered class IIb
medical devices unless they are implantable or long-term invasive medical devices, in
which case they will be included in class III.
Rule 15. All products specifically intended for the use of disinfection, cleaning, rinsing,
or hydrating contact lenses will be included in class IIb.
All products specifically intended for disinfecting medical devices will be included in
class IIa.
The present rule will not apply to products intended for cleaning medical devices other
than contact lenses by physical action.
Rule 16. Non-active medical devices intended specifically for recording diagnostic
radiographic images will be included in class IIa.
Rule 17. All medical devices made using animal tissues or derivatives thereof that have
been rendered unviable will be included in class III, except in cases where medical
devices are intended to come into contact only with intact skin.
Rule 18. Nevertheless the provisions of other rules, blood bags will be included in class
IIb.
CHAPTER III
Good manufacturing practices and certificates of storage and conditioning
capacity for medical devices
Article 8°. Good manufacturing practices for medical devices. Establishments
dedicated to manufacturing, semi-elaborating, bottling, and packing medical devices for
their operation, must comply with the Good Manufacturing Practices for Medical
Devices (BPM) issued for this purpose by the Ministry of Social Protection.
Article 9. Issuance of the good manufacturing practices certificate. The Instituto
Nacional de Vigilancia de Medicamentos y Alimentos, Invima, is responsible for issuing
the Certificate of Compliance with Good Manufacturing Practices for Medical Devices
and must verify its implementation and compliance by performing periodical visits.
Article 10. Storage and Conditioning Capacity Certificate for Medical Devices,
CCAA. All medical devices' importing and marketing establishments must comply with
the storage and packaging capacity requirements, which will be established by the
Ministry of Social Protection.
Article 11. Issuance of the Storage and Conditioning Capacity Certificate. The
Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima, is responsible
for issuing the Storage and/or Conditioning Capacity Certificate and must verify its
implementation and compliance by performing periodical visits.
Article 12. Gradual Implementation Plan. All medical device manufacturing
establishments covered by the present decree must submit to the Instituto Nacional de
Vigilancia de Medicamentos y Alimentos, Invima, within the following year the adoption
or issuance of the Good Manufacturing Practices by the Ministry of Social Protection, a
gradual implementation plan for compliance not exceeding two (2) years, which allows
the implementing development and application of BPM, which will be subject to
verification by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos,
Invima.
Once the term indicated for compliance with the BPM has expired, the manufacturers
or those responsible for the medical device that do not comply with the provisions of the
present decree will be subject to the sanitary security measures and the sanctions in
the law contemplated.
The establishments that require the Certificate of Storage and/or Conditioning Capacity
for Medical Devices, CCAA, within six (6) months from the adoption or issuance of the
requirements, must present a gradual implementation plan for compliance that does not
exceed one (1) year for obtaining the certificate.
Paragraph. While the Good Manufacturing Practices, BPM, are implemented, the
Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima, will issue the
Technical Concept of Sanitary Conditions for which it will perform inspection visits to
the establishments that manufacture and condition medical devices in order to verify
the sanitary, hygienic, technical and locative and quality control conditions.
Article 13. Of the requirements for requesting an inspection visit to certify good
manufacturing practices and the storage and conditioning capacity. For the
opening of a medical device manufacturing establishment, a request for an inspection
visit must be submitted to the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, for certifying compliance with Good Manufacturing Practices for
Medical Devices and/or Storage and Conditioning Capacity as the case may be, to which
the following documentation must be attached:
a) Name of the establishment's owner or legal representative;
b) Establishment's name or business name and address;
c) Certificate of incorporation and legal representation of the establishment or commercial
certificate for a natural person, issued by the Chamber of Commerce, which must have an
issue date of less than thirty (30) days;
d) Control techniques and quality guarantee of the product and manufacturing process;
e) Organization chart of the manufacturing establishment;
f) Architectural plan of the manufacturing establishment's distribution;
g) List of equipment available;
h) List of medical devices to be developed along with the pertinent information that
describes them;
i) Proof of consignment receipt for the visit's value in accordance with the current Tariff
Manual of the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima;
j) In the opinion of the Instituto Nacional de Vigilancia de Medicamentos y Alimentos,
Invima, additional documentation necessary for the visit may be requested.
In the case of the Storage and Conditioning Capacity Certificate, CCAA, it is not
required to comply with the provisions of literals d) and h).
The Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima, will perform
the visit to the establishment in a period not exceeding ninety (90) business days from
the date on which the application is delivered, as long as the documentation presented
is complete.
When the visit's result establishes that the entity does not comply with the Good
Manufacturing Practices for Medical Devices, or with the Storage and Conditioning
Capacity, the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima,
must leave a written record of such fact and will make the pertinent recommendations
that must be corrected by the interested party in a term not exceeding sixty (60) days.
Once the recommendations have been made, a new verification visit must be requested
for the compliance concept to be issued.
If after the verification visit the recommendations are not complied with in accordance
to the visit performed by the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, the request will be understood to have been withdrawn and therefore
the process must be started again.
Once the Good Manufacturing Practices for Medical Devices Certificate, BPM, or the
Storage and Conditioning Capacity Certificate, CCAA, have been issued, and if in use
of its inspection, surveillance, and control powers the competent health authority finds
that the establishment does not comply with the technical and sanitary conditions
established in the current legal regulations, it will proceed to apply sanitary security
measures, if applicable, without prejudice to the imposition of the sanctions it deems
appropriate.
Paragraph. Compliance with Good Manufacturing Practices, BPM, of the
establishments that manufacture the products object of the present decree will be
issued specifying the production areas and the type of product authorized to be
manufactured.
Article 14. Certification of a new production area. When the natural or legal person
responsible for an establishment already has a Good Manufacturing Practices for
Medical Devices Certificate and requires the opening or expansion of a new production
area, they must have for its authorization, the certification issued by the competent
health authority on the corresponding area evaluation, accompanied by the respective
visit record. In this case, the certification will be issued following the same procedure
provided for the issuance of the work initiation certification of an establishment.
Article 15. Of the validity of the certificates. Article 15. Of the certificate's validity. The
Good Practices, Storage, and Conditioning Capacity Compliance Certificates will be
valid for five (5) years from the issuance date.
These certificates may be renewed for a period equal to their initial validity, for which
the indicated procedure for new applications will be followed.
CHAPTER IV
The Regime of Sanitary Records
Article 16. Sanitary Records. Medical devices and biomedical equipment that are not
IIb and III class controlled technology, require for their production, importation,
exportation, processing, bottling, packaging, storage, sale, and marketing of a sanitary
registration issued by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos,
Invima, prior compliance with the technical-scientific, health, and quality requirements
provided in the present decree.
Article 17. Automatic Sanitary Registration. Medical devices and biomedical
equipment that are not class I and IIa controlled technology, require for their production,
importation, exportation, processing, bottling, packaging, storage, sale, and marketing
of an automatic health registration issued by the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, prior compliance with the requirements outlined in
the present decree.
Article 18. Documentation for the technical evaluation of non-controlled technology
medical devices and biomedical equipment. The technical evaluation aims to
conceptualize the technical capacity of the manufacturer, the manufacturing process, the
quality of the product including the safety and health protection characteristics, as well as
the functionality of the medical device in the indicated field of application.
To request this evaluation, the following information must be attached and must be signed
by the responsible person of manufacturing:
a) Duly completed form endorsed by the technical director, which must indicate:
1. Generic name or brand name of the medical device.
2. Commercial presentation.
3. Name of the manufacturing industry.
4. Registration mode.
5. Useful life, when applicable.
6. Classification according to risk.
7. Indications and uses.
8. Indicate the international code (ECRI, GMDN, or another of equal international
recognition).
9. Warnings, precautions, and contraindications;
b) Copy of the quality system used certification, CCAA or BPM or its equivalent. The
Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima, may verify the
quality conditions when it deems it pertinent;
c) Medical device description: List of the main parts of which the product is made and its
composition when applicable, specifications, operation, descriptive information;
d) Technical studies and analytical checks. Summary of the verification and validation
documents (test report) of the design or analysis certificate of the finished product
containing the specifications, indicating the values or acceptance ranges. In the case of
biomedical equipment it is required to establish that the design complies with current
specific standards and technical regulations thereof;
e) Sterilization method, when applicable;
f) Disposal method or final disposal of the product, when applicable;
g) Final arts of labels and inserts, as provided in the present decree;
h) Declaration by the owner or the authorized importer in the case of biomedical
equipment, stating that it has Spanish operation and maintenance manuals, as well as
the commitment to present them at the request of the competent health authority and
their delivery at the time of acquiring biomedical equipment;
i) When it is necessary to request additional information to evaluate the medical device
safety, the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima, may
request such information after technical justification;
j) Class IIa, IIb, and III devices must include the necessary scientific information to
support the product's safety, risk analysis of the medical device according to its
indications, a description of the solutions adopted to meet essential safety and
performance requirements, and if applicable, a list of specific standards totally or
partially applied;
k) Class IIb and III devices must submit clinical studies on use to demonstrate safety
and effectiveness;
l) Certificate of free sale under the parameters established in literal b) of Article 29 of
the present decree.
Paragraph 1. The technical direction of the establishments dedicated to the manufacture
of medical devices will be in charge of a professional with specific experience or
specialization in the field.
Paragraph 2. Compliance with the technical regulations issued by the Ministry of Social
Protection for medical devices will be a mandatory requirement in the process of
obtaining the health registration when applicable.
Article 19. Of the legal evaluation. The legal evaluation includes the legal study of the
documentation that is provided by the interested party for the bestowal of the sanitary
registration and its conformity with the legal norms that regulate the mentioned matters.
The information and documentation that the petitioner must submit for this evaluation are
the following:
a) Name or business name of the natural or legal person in whose name the registration
is requested, proof of existence and legal representation of the manufacturer and/or the
owner;
b) Power to manage the procedure, which may be granted to a lawyer if applicable;
c) Receipt for rights of the sanitary registration issuance.
Article 20. Of the content of the health registry and the automatic health registry.
Any administrative act through which non-controlled technology medical devices and
biomedical equipment are granted a health registration must contain at least the
following information:
a) Sanitary registration number preceded by the acronym DM;
b) Validity of the sanitary registration;
c) Name and address of the sanitary registry holder;
d) Name of the product;
e) Name and address of the manufacturing laboratory or establishment.
f) Type of medical device and its classification according to risk;
g) Qualitative composition according to the case;
h) Use or indications of the product;
i) Modality under which the sanitary registration is granted;
j) Name and address of the importer;
k) Authorized commercial presentations;
l) Observations if any (references, systems and subsystems, authorized models, special
precautions, and an indication of the product's useful life, when applicable).
Article 21. Procedure for obtaining the sanitary registration. In order to obtain the
sanitary registration, the interested party must proceed with the following procedure:
a) Filling out the format for obtaining the sanitary registration, which will be provided by
the Instituto Nacional de Vigilancia de Medicamentos y Alimentos,
Invima, in accordance with the instructions attached to it and present the technical and
legal documentation required in the present decree;
b) Filing the documentation with the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, which will verify it is complete. Otherwise, it will be recorded in
accordance with the provisions of the Contentious-Administrative Code. This procedure
will not require a lawyer;
c) In the event that it is necessary to add or clarify the information provided, the
interested party will be requested only once to provide it within the following ninety (90)
days counted from the date of the request. If within this period the information is not
received, it will be understood that the request is withdrawn and, consequently, the
Invima will proceed to declare the withdrawal of the application for the sanitary
registration without there being a refund for the money corresponding to the rate .
Paragraph. The health authority may require samples at any time or take them from the
market so that the pertinent technical analyzes can be carried out without the
presentation thereof constituting a requirement for the issuance of the sanitary
registration.
Article 22. Procedure for obtaining the automatic health registration. To obtain the
automatic sanitary registration, the interested party must proceed with the
following:
a) The interested party must file with the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, the application to which the technical and legal
documentation required for the issuance of the automatic health registration will be
attached. The Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima,
will verify that the duly requirements are complete;
b) When all the requirements are met, the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, within the two (2) days following the evaluation of
the documents attached, will issue the corresponding administrative act;
c) If the documentation is incomplete at the time of receipt, the request will be rejected
outright, if the petitioner insists on filing it the provisions of article 11 and subsequent of
the Contentious-Administrative Code will be applied.
Paragraph. In accordance with the powers of inspection, surveillance, and control, the
competent health authority may at any time verify the information provided to obtain the
automatic health registration, taking into account the medical device's risk.
If from the verification result the health authority requires additional information, it may
request it from the interested party only once, who will have a period of ninety (90)
business days for collecting it. If the information is not attached in this term, it will be
understood that the registration is suspended and therefore, without effect.
After three (3) months from the suspension of the sanitary registration without correcting
the situation, the registration will be canceled.
CHAPTER V
Of the equipment biomedical of technology controlled
Article 23. Marketing permit. Controlled technology biomedical equipment requires a
marketing permit for its production, importation, exportation, marketing, and sale in the
country, which will be granted by the Instituto Nacional de Vigilancia de Medicamentos
y Alimentos, Invima, in accordance with the requirements and procedures indicated in
the present decree.
Controlled technology biomedical equipment that uses radiation must have an
authorization issued by the competent authority in the matter for handling this kind of
equipment.
Article 24. Of the requirements for the marketing permit. In order to obtain the marketing
permit for manufactured and imported biomedical equipment, in addition to the
documentation for obtaining the health records referred to in the present decree, the
following additional documentation must be attached:
a) Certificate or proof of the equipment's compliance with international quality standards
(brand and model), issued by a national or international entity with experience and
recognition. The Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima,
will define the entities recognized to issue said certifications or constancies for each
country of origin;
b) Name and location of the Health Service Provider Institution, IPS, where the
equipment will be installed or commitment to report it in case it has not yet been
marketed.
c) Declaration issued by the manufacturer or by the equipment's representative in
Colombia stating the following:
1. That the equipment under acquisition object is not in experimentation.
2. Biomedical equipment indications and uses.
3. That they are capable of providing supplies, parts, spare parts, and maintenance services
for at least five (5) years, or during the useful life of the equipment if less.
4. That they will provide the user with the programs and mechanisms for the training of
operators and maintenance engineers or technicians.
5. That they will supply the user with the operation, installation, and maintenance manuals
in the original language and Spanish.
Paragraph 1°. In the case of importations, the importer may present a certificate or proof
of the manufacturer's quality system issued by a national or international entity with
experience and recognition in this field, specifying compliance with quality standards in
the manufacture of biomedical equipment for replacing the quality certificate indicated
in this article and accompanied by a compliance declaration indicating the model of the
equipment to be imported and the product's free sale certificate.
Paragraph 2°. The marketing permit issued by the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, may cover several equipment models of the same
brand and technology as long as the technical concept so provides.
Paragraph 3°. The marketing permit holder for biomedical equipment classified as
controlled technology must prepare an annual report specifying the quantity of imported,
manufactured, and sold equipment, the series of each equipment, its geographical and
institutional location, and reports of serious adverse effects events presented during
their use, the actions taken regarding them, as well as the information that the
competent authorities require in accordance with the control of this technology. The
omission or inaccuracy of this information's provision will lead to the sanctions
established in the present decree.
The Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Invima, will collect
this information, as well as the one related to the equipment, and will send it to the
Ministry of Social Protection.
Paragraph 4°. The spare parts for the maintenance and technical support of imported
biomedical equipment must have the marketing permit for the biomedical equipment
intended to be repaired, maintained, or supported.
Companies whose corporate purpose includes importing spare parts for specific
biomedical equipment must report imports thereof to the Instituto Nacional de Vigilancia
de Medicamentos y Alimentos, Invima.
Article 25. Of the marketing permit content. Any certification by which a marketing
permit is granted for controlled technology biomedical equipment must contain the
following information at a minimum:
a) Marketing permit number preceded by the acronym EBC;
b) Permit's validity;
c) Marketing permit holder's name and address;
d) Product's name;
e) Manufacturing establishment's name and address;
f) Importer's name and address;
g) Type of biomedical equipment and its classification according to risk;
h) Main systems and subsystems that integrate the biomedical equipment;
i) Product's use or indications;
j) Special precautions and others;
k) Modality under which the marketing permit is granted;
l) Authorized model.
Article 26. Marketing permit suspension. The Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, may suspend the importation and sale of biomedical
equipment classified as a controlled technology medical device when it is demonstrated
that there is a risk to the individual or collective human health.
CHAPTER VI
Health records and marketing permits' common provisions
Article 27. Modalities. Sanitary registrations for medical devices and the marketing
permit for controlled technology biomedical equipment will be issued for the following
modalities:
1. Manufacturing and selling.
2. Importing and selling.
3. Importing, packaging, and selling.
4. Importing, semi-elaborating, and selling.
Paragraph 1. The registration modality indicated in numeral 2 of the present article
includes by itself the possibility of exporting.
Paragraph 2. The registration modality contained in numeral 4 of the present article
corresponds to importing, assembling, and selling.
Article 28. Protection of several medical devices in the same sanitary registry.
Medical devices with the same risk classification, usage, and generic denomination that
belong to the same owner and manufacturers, that present differences in terms of
organoleptic properties, size, or characteristics that do not significantly modify their
indication or that are used together forming what may be called a system or kit, may as
well be protected under a single health registration according to the class of medical
device.
Article 29. Of the medical devices sanitary registrations and imported controlled
technology biomedical equipment marketing permits. For medical devices health
registrations or imported controlled technology biomedical equipment marketing permits
issuance, the indicated procedure for the health registration, automatic health
registration, or marketing permit issuance must be followed as it corresponds, taking
into account the following additional requirements:
a) A medical device's commercial history that references some countries in which the
medical device is sold and alerts related to the mentioned device;
b) Certification from the origin country's competent authority stating that the product has
been authorized for production or marketing in the territory of the origin country. If the
product to be imported is not used in the origin country, the health entity certificate
stating that it is freely sold in a reference country (European Economic Community,
United States of North America, Canada, Japan, and Australia), or with countries where
a mutual recognition agreement exists;
c) Proof of constitution, existence, and legal representation of the owner, manufacturer,
and importer issued by the competent body in the origin country;
d) Document issued by the manufacturer or its authorized agent establishing who is
empowered to import and/or market, and/or to be the marketing permit's holder.
Paragraph. In the event that it is necessary to add the provided information, the
interested party will only once be requested to provide it, for which the applicant will
have a term of ninety (90) days counted from the requirement's communication date. If
the interested party does not submit the requested information within this period it will
be understood that the request is withdrawn and, consequently, the Instituto Nacional
de Vigilancia de Medicamentos y Alimentos, Invima, will proceed to declare the
request's withdrawal and return the files to the petitioner.
Such a situation does not give place for refunding the money corresponding to the fee
paid.
Article 30. Health records modifications. Sanitary registrations will not be modified
when there is a significant change in the medical device that may affect its safety and
effectiveness or when the modification implies changes in the design, material's
chemical composition, energy source, or manufacturing processes. In all other cases,
the modifications that entail the change of the administrative act content by which the
sanitary registration was granted, must have an application filed with the Instituto
Nacional de Vigilancia de Medicamentos y Alimentos, Invima, attaching the respective
technical and/or legal documents that support the corresponding modification along with
the due payment receipt within thirty (30) business days prior to the date marketing
begins under the mentioned modification.
Once the petitioner files the required information, the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, will have a term of thirty (30) business days to
respond to the request.
Modifications to the health registration may happen in the case of a minimal modification
to accessories that do not affect the safety and effectiveness of the medical device or
non-controlled technology biomedical equipment.
Paragraph. In the case of controlled technology biomedical equipment that has a
marketing permit, any modification or adjustment will require a new technical concept.
Article 31. Health records and marketing permit validity. Sanitary registries and
marketing permits will be valid for ten (10) years from the issuance of the corresponding
administrative act.
The holder of these records or permits may request their cancellation at any time.
Article 32. Of the health registrations and marketing permits renewals. Health
registration and marketing permit renewal will be performed following the same
procedure of its issuance in what refers to the technical and legal evaluations. For the
same, manufacturing process' quality control analysis and evaluation, and of
compliance with current Good Manufacturing Practices for Medical Devices, BPM, may
be performed when applicable.
Sanitary registrations and marketing permits referred to in the present decree will be
renewed under the same initial number but followed by the letter R, added with the numbers
1, 2, and on.
The renewal request must be filed with the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, three (3) months prior to the expiration of the
respective health registration or marketing permit.
Any application for the renewal of a health registration or marketing permit that is not
submitted within the established term will be processed as a new application.
Paragraph 1°. Paragraph 1. If the respective health registration or marketing permit has
expired without the renewal application being submitted, if the application is being
abandoned or withdrawn, or if the application has not been submitted within the term
set forth herein, the corresponding product may not be imported nor manufactured into
the country as the case may be. If there are stocks in the market, the Instituto Nacional
de Vigilancia de Medicamentos y Alimentos, Invima, will give the interested parties a
term to dispose of them, which may not exceed six (6) months. If after this period there
are products on the market, the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, will order their confiscation in accordance with the provisions in the
present decree.
Paragraph 2°. If the scientific information in the file has not changed and is still valid at
the time of requesting the renewal, the information should not be attached again and
instead, the owner will submit a statement to that effect.
Article 33. Of the revision's object. The Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, may order at any time or under the Ministry of
Social Protection's request, the review of a controlled technology medical device or
biomedical equipment covered by a health registration or marketing permit with the
purpose of:
a) Determinating if the controlled technology medical device and biomedical equipment
and its commercialization comply with the provisions on the matter;
b) Updating the specifications, processes, and processes' validation in accordance with
the scientific and technological advances that occur in the field of medical devices and
other products covered by the present decree, when the advances must be adopted
immediately;
c) Adopting immediate measures when national or international information becomes
known about the side effects or contraindications of any of the medical devices and
biomedical equipment covered by the present decree, detected during their marketing
and that endanger the users' health.
Article 34. Of the procedure for the revision. The procedure to be followed in the case
of revision of a controlled technology medical device or biomedical equipment will be:
a) Through the reasoned resolution issued by the General Director of the Instituto
Nacional de Vigilancia de Medicamentos y Alimentos, Invima, prior concept of the Invima
Review Commission or the Ministry of Social Protection, in accordance with the medical
device or biomedical equipment classification, the ex officio review of a product or group
of products covered by a health registration, automatic registration or marketing permit,
will be ordered. This decision must be notified to the interested parties in order for them
to present the studies, technical justifications, compliance plan, or adjustments they
consider for the case depending on the reasons that motivate the review. The Instituto
Nacional de Vigilancia de Medicamentos y Alimentos, Invima, will determine the term for
the support presentation that may apply;
b) If the reasons that generate the ex officio review show that there may be third parties
affected or interested in the decision, the resolution will be made known to them as
provided by the Contentious-Administrative Code;
c) During the term that is set for the interested party to respond, the competent entity
may perform the product analyses considered appropriate, request reports, concepts
from experts in the field, information from the health authorities of other countries, and
any other measure considered for the case and that is related to the circumstances that
generate the review;
d) Based on the foregoing, on the information and the documents referred to in
subparagraph a) of the present article, prior concept of the Ministry of Social Protection
or the Review Commission of the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, through reasoned resolution, Invima will adopt the decision of the
case which must be notified to the interested parties;
e) If the review reveals that there may be behaviors violating health regulations, it will
proceed to adopt the pertinent measures and initiate the duly sanctioning processes.
CHAPTER VII
Common provisions to the previous chapters
Article 35. General requirements for controlled technology biomedical equipment.
Without prejudice to the provisions of the preceding articles, in the case of controlled
technology biomedical equipment, the following requirements must be taken into account:
a) The natural or legal persons that acquire biomedical equipment must have the operation,
functioning, and maintenance manuals at all times, which will be mandatorily provided by
the distributor at the time of delivering the equipment;
b) The owner or importer of the biomedical equipment must guarantee the ability to offer
permanent technical support service during its useful life, as well as the spare parts and
tools necessary for maintenance and calibration that allow the equipment to be kept within
the safety ranges initially established by the manufacturer;
c) The companies that produce biomedical equipment, their representatives in the country,
and marketing permits holders must have technical managers with a university degree
and/or specialization in the specific area for the processes of acquisition, installation, and
maintenance of this type of technology;
d) The products must be designed, manufactured, and packaged in such a way that the
characteristics and functions are not altered according to their intended use during storage
and transport, taking into account the instructions and data provided by the manufacturer.
Article 36. Prototype controlled technology medical devices and biomedical
equipment. National or imported prototype controlled technology medical devices and
biomedical equipment may only be authorized for research and experimentation
purposes and, in no case be used for health care.
For the importation of prototype controlled technology medical devices and biomedical
equipment, a technical concept issued by the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, will be required in accordance with the contemplated
in the current provisions for health research.
The Ministry of Social Protection will define the minimum requirements for the
development and use of national production prototype medical devices and biomedical
equipment of controlled technology.
Article 37. Medical devices considered as used or repowered biomedical
equipment. The importation, acquisition, or donation of class I or IIa used biomedical
equipment may be authorized, which will be considered as controlled technology.
The importation, acquisition, or donation of classes IIb and III used biomedical
equipment may not be authorized.
For the commercialization and sale of used class I or IIa biomedical equipment in the
country, prior to its import registration, the following documentation must be attached:
a) The requirements established for the marketing permit;
b) Certificate issued by the manufacturer or its representative in the origin country or
importer, stating that the equipment is no more than five (5) years old and that it is in
optimal operating and functioning condition, including its security systems;
c) Equipment's serial number;
d) Equipment's manufacture date.
Class I, IIa, IIb, and III repowered biomedical equipment will be allowed to enter the
country as long as it meets the biomedical equipment requirements and is
accompanied by the certificate of proper functioning issued by the legal
manufacturer or its representative in the country and it has the same documentation
required for used biomedical equipment attached. These imports will be considered
as controlled technology.
Repowering may in no way alter the initial design of the equipment and the
manufacturer or its official representative, or the manufacturer's authorized
repowerer must guarantee that the biomedical equipment has the same
characteristics and effectiveness as new.
Repowered equipment may only be imported or marketed by the manufacturer or
the authorized repowerer.
Paragraph 1°. All medical devices designed to be used only once are excluded from the
provisions of the present article.
Paragraph 2°. The biomedical equipment that enters the country through a donation must
be assigned solely and exclusively to an Institution that Provides Health Services and
must not be in the experimentation stage; In addition, it must comply with the current
customs regulations in the country and may not be marketed or used for profit.
Paragraph 3°. The newly donated equipment corresponding to classes I, IIa, IIb, and III
that any Health Service Provider Institution imports, acquires, or receives, will be of
controlled importation and must comply with the provisions of the present decree.
Paragraph 4°. The Ministry of Social Protection will regulate matters related to the
importation of used, remanufactured, and/or repowered biomedical equipment in the
country.
Until the Ministry of Social Protection issues the pertinent regulations, repowered or
remanufactured biomedical equipment will be considered used equipment.
Article 38. Post-sale of medical devices considered biomedical equipment and
their maintenance. In the post-sale stage of biomedical equipment, the responsibility
for the operation of the equipment is shared between the manufacturer, or its
representative in Colombia in the case of imported equipment, and the owner or holder.
In the post-sale stage of medical devices considered biomedical equipment, the
manufacturer or importer must offer the services of verifying the calibration,
maintenance, and provisioning of supplies and spare parts, as well as the required
training in both operation, and basic maintenance of the equipment. The holder will be
responsible for the proper functioning of the medical device considered biomedical
equipment, which must be directly guaranteed or by contracting the services of the
manufacturer, importer, or with a third party according to the parameters established in
the present decree.
The biomedical equipment's owner or holder must ensure that thereof use and
operation are in accordance with the provisions of the manuals delivered by the
manufacturer at the time of its sale, as well as its calibration and maintenance.
Paragraph 1°. The Health Promoting Entities may not contract with Health Service
Provider Institutions that do not keep control of maintenance, calibration and verification
records, and other requirements established by the manufacturer for the safe operation
of the biomedical equipment with which the health service will be provided.
The competent health authority will verify that the Health Service Provider Institutions
comply with these obligations.
Paragraph 2°. The Health Service Provider Institutions may only contract the
maintenance of medical devices considered controlled technology biomedical
equipment with third parties when they demonstrate the technical capacity to provide
this type of service. In this case, the third parties will be responsible for the operation of
the equipment.
Paragraph 3°. The Health Service Provider Institutions must keep records of the
maintenance activities performed by them or by third parties for the programming and
control of medical devices considered controlled technology biomedical equipment.
These records may be requested by the health authorities when they deem them
pertinent.
Article 39. Human resource for the maintenance of medical devices considered
biomedical equipment Any legal or natural person that provides maintenance and
calibration verification services for Class IIb and III biomedical equipment must have a
technical manager, who must be a professional in biomedical engineering or related
engineering or duly accredited technical personnel, who must register with the Instituto
Nacional de Vigilancia de Medicamentos y Alimentos, Invima, or the competent health
entity.
Article 40. Implantable medical devices. Without prejudice to what is stated in the
present decree for implantable medical devices, the Health Service Provider Institutions
must fill out the implant card in triplicate, which must indicate at least the following:
a) Product name and model;
b) Batch number or serial number;
c) Manufacturer's name and address;
d) Name of the institution where the implantation was performed and the procedure's
date;
e) Patient's identification (citizenship card number, passport number), and will be
completed by the IPS once implanted.
Paragraph. One of the copies will remain on file in the patient's medical record, the other
one will be provided to the patient and the last one will be sent to the supplying
company.
In the event that a national registry of implants has been arranged, this last one or its
copy will be sent to the national registry by the supplying company.
Article 41. Raw material importation. For raw material importation that requires sanitary
registration for the manufacture of the products covered by the present decree, the
interested party must submit a photocopy of the sanitary registration and the analytical
certificate of the raw material to the Ministry of Commerce, Industry and Tourism, which will
be subject to control and surveillance by the competent health authority.
Article 42. Registry of the controlled technology biomedical equipment marketing
responsible individuals. Every marketer of controlled technology biomedical equipment
must notify the competent health authorities of their address and the description of the
marketed products.
Article 43. Importation registry. For the respective importation registry of controlled
technology medical devices and biomedical equipment, the importer must attach the
respective sanitary registration or marketing permit as the case may be.
The importation registry must specify the brand and models of the medical devices to be
imported and whether they are new or used.
Article 44. Documents issued abroad. When the documents required in the present
decree are issued abroad and correspond to official information, they must be
authenticated by the respective Colombian consul and by the Ministry of Foreign Affairs
or, if applicable, with an Apostille seal in compliance with Articles 65 and 259 of the
Code of Civil Procedure as the case may be, and they will require an official translation
when they are not in Spanish. The issuance date of these documents will have the
validity that the same document specifies. In the event that the document does not
establish said term, it shall be understood as one (1) year.
Article 45. Demonstrations. In the fairs, exhibitions, and demonstrations, products that
do not comply with the provisions of the present decree may be presented, provided
that they are previously authorized for that purpose. These products cannot be
marketed or put into service until they have the corresponding health registration or
marketing permit. Such demonstrations may never involve the use of products in
patients when they have not yet been approved in the origin country or reference
countries.
Article 46. Of the marketing. For the sake of the protection and guarantee of the
community's health, the holders of the sanitary registries referred to in the present decree
and controlled technology biomedical equipment marketing permits granted after its
validity will have a period of thirty-six (36) months to market the product, counted from
the date of the administrative act or respective code that has been granted to them. The
non-commercialization within this term will lead to the automatic cancellation thereof.
The holder of a health registration or marketing permit who, for fully justified reasons,
cannot comply with the obligation set forth herein, must state such circumstance in a term
not exceeding one (1) month from the expiration of the term, before the Instituto Nacional
de Vigilancia de Medicamentos y Alimentos, Invima, or the competent health entity. Said
entity may proceed in such a case, only once, to set a new term for the commercialization
of the product by reasoned resolution.
Article 47. Of the permanence and information of the products or sellers in the
market. The holders of the respective sanitary registries or marketing permits for the
products covered by the present decree who wish to withdraw their products from the
market must previously inform the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima.
The holders of the marketing permit for controlled technology biomedical equipment that
no longer have representation in Colombia must guarantee the case's technical support
in the country during the validity of the permit.
Article 48. Of the special measures. The Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, may exceptionally authorize the import of
finished products covered by the present decree without having obtained the
corresponding health registration or marketing permit. For this, an application will
be required accompanied by a certificate that demonstrates the free sale issued by
the competent authority of the origin country, proof of the constitution, existence,
and representation of the petitioner, and the product quality certificate, in the
following cases:
a) When circumstances of calamity or emergency determined by the Ministry of Social
Protection arise;
b) In the case of controlled technology medical devices or biomedical equipment for which
the Ministry of Social Protection or the Instituto Nacional de Vigilancia de Medicamentos
y Alimentos, Invima, has authorized clinical research in the country prior the concept of
the Committee for the Evaluation, Monitoring and Regulation of Health Technology of the
Ministry of Social Protection or the Specialized Room for Health Supplies and
Miscellaneous Products of the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima;
c) In the case of unavailable medical devices or vital biomedical equipment except in
cases where they are in the clinical research phase or have substitutes on the market. In
this case, it will be necessary to add the full name of the patient and a summary of the
clinical history.
The importation of unavailable medical devices or vital biomedical equipment may be
carried out by any person.
Article 49. Technical and scientific information language. The technical or scientific
information may be submitted in English with an official translation into Spanish.
Article 50. Of the sale. The Ministry of Social Protection will regulate matters related to
authorized establishments for selling the products referred to in the present decree.
CHAPTER VIII
Packaging, labeling and advertising
Article 51. Packaging. The packaging systems must be such that they preserve the
product without damaging it or causing detrimental effects on the content. The material
and design of the container must ensure:
a) The maintenance of the content's sterility, if applicable, taking into account that it is
stored in conditions of humidity, cleanliness, and adequate ventilation;
b) A minimal risk of contamination during the container's opening and content's extraction;
c) A minimal risk of contamination during normal handling, transit, and storage;
d) That when the package has been opened, it cannot be easily resealed and must show
evidence of its opening;
e) That the product's packaging allows the distinction between identical or similar
products sold in both sterile and non-sterile forms.
Article 52. Lettering and labeling specific requirements. Controlled technology
medical devices and biomedical equipment manufacturers must apply the lettering and
labeling specific requirements issued by the Ministry of Social Protection for this purpose.
Article 53. Labeling general provisions. For the information referred to in the labels, the
following general provisions are established:
a) The information necessary to identify and use the device safely must be provided on
the device itself, and/or on the packaging of each unit, and/or on the packaging of multiple
devices. If individual packaging of each unit is not feasible, the information should be set
out in the brochure, package insert, or other supplied media with one or multiple devices;
b) The format, content, and location of the labeling must be appropriate for the
particular device and for the purpose for which it was manufactured;
c) The use of internationally recognized symbols must be taken into account as
long as the safety of the device is not compromised by a lack of understanding by
the patient or user;
d) The information on the device's use and the instructions will be provided to the
user in various media and through printed documents, through a display screen
integrated into the device, by magnetic or optical means, etc.
Whatever the means are the information should be directed at the intended users'
population;
e) The usage instructions must be written in terms that are easy to understand
for the user.
Article 54. Information on container labels. The packaging labels must contain in
Spanish at least the information listed below:
a) Product’s name;
b) Batch or serial number;
c) Expiration date when applicable;
d) Sanitary registration number or marketing permit;
e) Manufacturer and/or importer with address;
f) Special legends such as “sterile”, or “use only once”.
Article 55. General information. According to the type of medical device and when
applicable, the labeling must contain the following:
a) The generic name or brand and the address of the manufacturer, as well as the
intended purpose and the patients and users population for the device, when applicable;
b) In the case of imported devices it is required that the label, packaging, or instructions
for use also contain the name and address of either the importer in the country or the
manufacturer's authorized representative;
c) Data for the user to identify the device and the contents of any packaging when
applicable;
d) Indication of the code or batch number (in single-use disposable devices) or the serial
number (in devices that work with electricity) as the case may be, that allows the
appropriate actions for tracking and obtaining the devices and removable components ;
e) Indication of the date until which the device can be used safely expressed in terms of
year and month (in single-use disposable devices) as the case may be;
f) In the case of devices other than those covered in literal (d) of this article and as
appropriate for the type of medical device, an indication of the date of manufacture. This
indication can be included in the batch code or serial number;
g) Any special condition for storage and/or handling of the outer packaging;
h) Any warning and/or precaution that must be taken;
i) The manufacturer's intended performance and all undesirable side effects;
j) The necessary information for verifying if the device is properly installed and can
function correctly and safely, as well as details on the nature and frequency of its
preventive maintenance, the replacement of consumption elements, and aspects related
to the necessary calibration for the device to function correctly and safely during its useful
life;
k) Details of any other treatment or handling required before the device can be used
(such as sterilization, final assembly, calibration, etc.);
l) Indication that the device is sterilized, as well as the necessary instructions in case of
damage to the sterilized packaging, and depending on the case, the description of the
methods for new sterilization;
m) Indication that the manufacturer has specified that the device should be used only
once;
n) Indication that the device is specifically for clinical and/or operational research prior
to market launch;
o) Indication that the device is intended only for presentation or demonstration
purposes;
p) If the device is to be installed or connected to other medical devices or equipment in
order to function for its intended purpose, sufficient details of its characteristics for
identifying the correct device or equipment to be used for obtaining a safe combination;
q) If the device is implantable, information concerning any particular risk related to its
implantation;
r) Information regarding the risks of reciprocal interference posed by the reasonably
expected presence of the device in the course of investigations or treatments (such as
electrical interference from electrosurgical devices or magnetic field interference from
magnetic resonance imaging equipment);
s) If it is a reusable device, information on the appropriate processes to allow reuse,
including cleaning, disinfection, packaging, and the method of resterilization and any
restrictions on the number of reuses when applicable.
In the case of devices that must be sterilized before use, the cleaning and sterilization
instructions must be such that, if followed correctly, the device complies with "the
fundamental requirements for the safety and operation of medical devices"
contemplated in Article 4 of the present decree;
t) If the device emits radiation for medical purposes, the details of the nature, type,
intensity, and distribution of this radiation;
u) The instructions for use must also include, as the case may be, details that allow
medical personnel to instruct the patient on any contraindications, warnings or
precautions to be taken;
v) The precautions to be taken in case of changes in the device operation;
w) The precautions to be taken regarding exposure, under reasonably anticipated
environmental conditions, to magnetic fields, external electrical influences, electrostatic
discharges, pressure or pressure variations, acceleration, sources of thermal ignition,
proximity to other devices, etc.
Article 56. Insert. When the controlled technology medical device or biomedical
equipment has an insert, it will contain sufficient information in Spanish to ensure the
proper execution of the procedure and its safe use.
The insert must be supplied with the controlled technology medical device or biomedical
equipment, without having to go inside its packaging.
Article 57. Of the labels, signs, and packaging of imported medical devices. The
labels, signs, and packaging of imported medical devices will be accepted as established
in the origin country.
In this case, an additional sign or label will be required in Spanish, that complies with
the provided in the general provisions for labeling and the information on labels referred
to in Articles 54 and 55 of the present decree, and add both the name and address of
the importer, as well as the sanitary registration number or marketing permit.
The importer's name and/or address, the sanitary registration and/or the marketing
permit number may be provided through the use of a sticker, as long as its use does
not cover or obscure any of the information on the label.
The product must be accompanied with the necessary information for its safe use and
to identify the manufacturer, taking into account the training and knowledge of potential
users. This information will consist on the indications that appear on the label and those
that appear in the instructions for use.
Article 58. Of the information and publicity. The scientific, promotional, or advertising
information on controlled technology medical devices and biomedical equipment will be
made in accordance with the conditions of the respective health registries or marketing
permits and current legal technical standards and must adhere to the truth, with scientific
evidence that proves it and therefore, the benefits that its use can offer cannot be
exaggerated in any case, it will not be possible to advertise controlled technology medical
devices and biomedical equipment, in the following cases:
a) When the general rules regarding health or therapeutic education are not applied;
b) In those that lead to deception or error;
c) When imputing, defaming, causing damage, or pejorative comparison to other brands,
products, services, companies, or organizations.
Paragraph 1. Medical devices that are part of the class I may be advertised in the mass
media, taking into account the specifications of the automatic health registration.
Medical devices and biomedical equipment of classes IIa, IIb, and III intended for exclusive
use by health professionals or prescribed by them, may only be advertised or promoted in
publications of a scientific or technical nature. Notwithstanding the foregoing, the health
authority may authorize other means of advertisement, promotion, or publicity.
Paragraph 2. The holders and/or marketers of the corresponding health records or
marketing permits will be responsible for any transgression of the provisions of this article
and the consequences that may result in individual or collective health.
CHAPTER IX
Control and surveillance
Article 59. Obligation to inform the health authority. The manufacturing
establishments, the corresponding sanitary registries and marketing permits holders,
users, and any other person who has knowledge of the existence of altered or fraudulent
products or facts related to them, whoever notices any dysfunction, alteration of the
characteristics or functions of the product, as well as any labeling or package insert
inadequacy that may lead or may have led to death or serious deterioration of the patient
or user's health status, must immediately notify the Sectional Directorates of Health of
the jurisdiction, with a copy to the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima.
When health professionals, competent authorities, manufacturers, or those responsible
for the products covered by the present decree notice any dysfunction, alteration of the
characteristics of the product, as well as any alteration of the labeling or the insert that
may result or may have resulted in the death or serious deterioration of a patient or a
user's health status, must notify the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, and inform the competent authority.
Article 60. Notification. It is the obligation of the corresponding health registration or
marketing permit holder or the manufacturer or representative of the controlled
technology medical device or biomedical equipment, and the users to notify the Instituto
Nacional de Vigilancia de Medicamentos y Alimentos, Invima, of all adverse incidents,
incorrect or improper use, as well as shortcomings in maintenance or other necessary
requirements for optimal operation and safety related to medical devices and biomedical
equipment that are marketed in the country.
The Sectional Directorates of Health will adopt the necessary measures to record and
evaluate the data submitted to their knowledge in accordance with the provisions of the
present decree on the circumstances related to:
a) Any malfunction, adverse effect, or alteration of the characteristics or functions, as
well as any inadequacy of the labeling or use instructions of a product that may lead or
may have led to death or serious deterioration of a patient or a user's health status;
b) Any reason of technical or health nature linked to the characteristics or presentations
of a product for the reasons indicated in subparagraph a) that has induced the
manufacturer to systematically withdraw from the market products belonging to the same
type.
In the event that the Sectional Directorates of Health find any circumstance related to
literals a) and b) of the present Article, they must inform the Instituto Nacional de
Vigilancia de Medicamentos y Alimentos, Invima, within the following two (2) business
days, for taking the appropriate measures.
Article 61. Of the national techno-surveillance program. The Ministry of Social
Protection with the support of the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, will design the Techno-surveillance Program that will allow the
identification of undescribed adverse incidents, quantify the risk, propose and create
health measures to reduce the incidence and to keep users, other health professionals,
health authorities at a national level, and the general population informed.
Article 62. Information on medical devices withdrawal from the market. The
manufacturer, registry owner, or the distributor of the products covered by the present
decree must inform the Instituto Nacional de Vigilancia de Medicamentos y Alimentos,
Invima, when taking preventative measures, alerting the products on the market, as well
as the dissemination of warnings related to medical devices.
Article 63. Of the medical devices traceability. Establishments that import or market
medical devices must maintain the documentation of the products that they distribute or
allocate for use in the national territory in order to trace the product, which must contain,
at a minimum, the following data: Trade name of the product, model, series and/or batch
number, date of purchase, date of shipment or supply and the first customer's
identification.
Article 64. Responsibility. The owners, manufacturers, importers, and marketers, or
those who have medical devices will be responsible for the veracity of the information
they provide both to the general public and to control entities, as well as compliance with
health regulations.
The adverse effects that the user population of medical devices may experience on
individual or collective health due to violation of established standards and/or conditions
will be the responsibility of the owners, manufacturers, importers, and marketers.
Article 65. Competition. The Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, in coordination with the Departmental or District Directorates of
Health and in accordance with its competencies will perform the inspection,
surveillance, and sanitary control actions and will apply the necessary preventive and
corrective measures to reach compliance with the provisions contained in the present
decree, in the same way, the sanitary security measures will be taken and there will be
an advance on the procedures and the sanctions that derive from non-compliance will
be applied.
Paragraph. For the purposes of surveillance, compliance with the regulations, and the
imposition of sanitary measures and sanctions referred to in the present decree, the
competent health authorities, in each case, will be considered as police, in accordance
with the provisions of Decree-law 1355 of 1970.
Article 66. Inspection visits. It is the obligation of the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, to perform periodic visits when it deems convenient,
to manufacturing establishments, distributors, etc., for verifying and guaranteeing
compliance with hygienic, technical-sanitary, and quality control conditions, established
in the present decree. Likewise, the conditions under which the commercialization was
authorized must be verified.
For class IIb and III medical devices, visits must be made at least once a year. For class
I and IIa medical devices, visits must be made according to the risk and periodic
sampling of the different products.
Out of every visit performed, there will be a triplicate record indicating the situation
evidenced and the technical concept of compliance or not compliance with the
requirements, which must be signed by the inspectors and the person in charge of the
establishment. In case they refuse to sign it, it will be done by witnesses.
When due to the effect of the visit performed by the Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, aspects arise that must be corrected, Invima will
establish a term without prejudice to the sanctions that may apply.
Article 67. Of the products sampling. The Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, may at any time collect samples of the products
covered by the present decree in order for them to be evaluated for the sake of control
and surveillance. The manufacturing or importing laboratory will assume the costs of
the medical devices taken as samples in the market.
Article 68. Sanitary measures. If in the exercise of the powers of inspection,
surveillance, and control the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, verifies that the establishment does not comply with the technical
and sanitary conditions that supported the issuance of the Good Manufacturing
Practices Compliance Certificate - BPM -, or the Storage and Conditioning Capacity
Certificate, CCAA, as the case may be, or if the controlled technology medical devices
and biomedical equipment do not meet the technical specifications that were reported
to obtain the respective health records and in general, any violation of the provisions of
the present decree will proceed to apply the corresponding health and safety measures.
Article 69. Application of sanitary security measures. The application of the sanitary
security measures will be performed by the competent authorities of ex officio or at the
request of any person.
Once the fact is known, or the information or request is received as the case may be,
the competent health authority will proceed to evaluate the situation immediately and
will establish whether or not there is a need to apply a security health measure as a
result of the violation of the precepts contained in the present decree or other health
regulations, or of the risks that it may cause to the individual or collective health.
Once the need to apply a safety health measure has been established taking into
account the type of service, the fact that originates the violation of the provisions of the
present decree and other health regulations, or the impact on the individual or collective
health, the competent health authority will impose the health security measure that may
be appropriate according to the seriousness of the fault, and in accordance with the
provisions of Article 576 of Law 09 of 1979.
Paragraph 1°. The products, raw materials, or equipment subject to the confiscation
measure may be destroyed by the Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima when health damage caused has been fully proven.
If no health damage is offered, they may be allocated to a non-profit entity in the health
sector. From this diligence, a record will be drawn up stating the quantity,
characteristics, and final destination of the products. In the event that they are allocated
to a non-profit entity, a record of such fact will be left and a confirmation of receipt by
the beneficiary will be attached.
Paragraph 2°. Sanitary security measures, without prejudice to the sanctions that may
apply, are of immediate execution, have a preventive and transitory nature, are not
subject to any appeal, and will be lifted when it is verified that the causes that originated
them have disappeared.
Article 70. Procedure for the application of sanitary safety measures. For the
purpose of applying a sanitary security measure, an act must be drawn up in triplicate to be
signed by the public official who practices it and the people who intervene in the diligence,
in which it must be indicated at least the address or location where it is practiced, the names
of the officials involved, the circumstances that gave rise to the measure, the type of
measure imposed, as well as the indication of the health provisions allegedly violated. A
copy of the same will be delivered to the person who attends the diligence.
If the person who is in the place where the diligence is performed refuses to sign the
minutes, this will be stated thereof and will be signed by witnesses. Paragraph. Once a
sanitary security measure has been applied, the corresponding sanctioning process must
be initiated immediately within which a record must be made stating the application of the
measure.
Article 71. Beginning of the sanctioning process. The sanctioning process will be initiated
ex officio or at the public official request due to a duly substantiated denunciation or
complaint filed by any person, or as a consequence of having adopted a health and safety
measure.
Once the fact is known, or when the complaint or notice has been received, or the health
safety measure has been applied, the competent health authority will order the
corresponding investigation to verify the facts or omissions that constitute a violation of the
health provisions.
The competent health authority may perform all those procedures considered appropriate,
such as visits, health inspections, sampling, laboratory tests, field tests, chemical tests,
expert opinion practices, and in general, all those that are considered necessary to establish
the facts or circumstances under investigation. The term for practicing this diligence may
not exceed two (2) months counted from the date of initiation of the corresponding
investigation.
In the event that the competent authority has the necessary elements, it must initiate
the process and immediately do the charges transfer, an event in which it must follow
the procedures established in the article on the charges' formulation of the present
decree.
The complainant may intervene in the procedure's course when the competent official
designated to perform the respective investigation considers it pertinent, in order to
expand the information or provide evidence.
Article 72. Cessation of the process. When the competent health authority
establishes, based on the procedures performed, that the fact under investigation did
not exist, that the alleged offender did not commit it, that the technical-sanitary
regulations do not consider it a sanction, or that the sanctioning procedure could not be
initiated or continued, it will dictate an administrative act that declaring so and will order
to file the sanitary procedure against the alleged offender. This act must be personally
notified to the one under investigation or their attorney. Failing that, notification will be
made by edict, in accordance with the provisions of the Contentious-Administrative
Code.
Article 73. Formulation of charges. If it is concluded from the procedures performed
that there is merit to transfer charges, the alleged offender will be personally notified of
the formulated charges and the file will be made available to them so that they can
request a copy of it at their expense; If the personal notification cannot be made, the
notification will be made in accordance with the provisions of Articles 44 and 45 of the
Contentious-Administrative Code.
Article 74. Discharges. Within ten (10) days following the charges' notification, the
alleged offender may directly or through a proxy present his discharge in writing, request
the practice of evidence, and provide the evidence in their possession.
Article 75. Article 75. Proofs. The competent health authority will decree on the practice
of tests that it considers conducive and will decide on those requested by the
investigated party, indicating for these purposes a term of fifteen (15) business days
that may be extended for an equal period, if in the initial term it has not been possible
practicing the decrees.
The car that decides on evidence will be notified by status unless some evidence is
denied, in which case the person under investigation will be notified personally and, if it
cannot be supplied, it will be notified by edict. Against the car who denies evidence will
proceed with the appeal for reconsideration.
Article 76. Failure. Once the term referred to in the previous Article has expired and
within forty (40) business days thereafter, the competent authority will proceed to
assess the evidence based on sound criticism and will decide on exonerating or
qualifying the fault and imposing the corresponding sanction.
Article 77. Aggravating circumstances. The following are considered aggravating
circumstances of a health infraction:
a) Repeat the offense's commission;
b) Perform the act with full knowledge of its harmful effects or unduly pressuring
subordinates or collaborators;
c) Avoid responsibility or attribute it to another or others without reason;
d) Violate several sanitary provisions with the same conduct;
e) Incurring an offense to hide another.
Article 78. Mitigating circumstances. The following are considered mitigating
circumstances of the health infraction:
a) Not having been sanctioned previously;
b) Seeking on their own initiative, to indemnify the damage or compensate for the
damage caused before the initiation of the sanctioning procedure;
c) Reporting the offense voluntarily before it causes damage to the individual or
collective health.
Article 79. Exemption from responsibilities. If it is found that there has been no violation
of the sanitary provisions referred to in the present decree, the corresponding
administrative act will be issued by means of which the presumed offender is declared
exempt from liability and the file will be ordered to be archived.
Article 80. Imposition of sanctions. When the violation of the health provisions referred
to in the present decree has been demonstrated, taking into account the seriousness of
the fact and through a reasoned resolution, the health authority will impose one or more of
the following sanctions in accordance with article 577 of the 09th Law from 1979:
a) Admonition: Consists on a call of attention made in writing by the health authority whose
purpose is to show the consequences of the fact, activity, or omission, which will be applied
to whoever violates any of the health provisions without the violation involving risk to
people's health or life.
The reprimand letter will specify the term given to the offender to comply with the health
provisions violated, if applicable;
b) Penalty fee: It consists of the pecuniary sanction imposed on an offender for the
execution of an activity or omission of conduct that entails the violation of current health
provisions.
According to the nature and qualification of the offense, the Instituto Nacional de Vigilancia
de Medicamentos y Alimentos, Invima, may impose fines, of an amount to ten thousand
(10,000) daily legal minimum wages in force at the time the respective resolution is issued.
The fines must be canceled in the entity that imposed them, within five (5) business days
following the execution of the ruling that imposes them.
Failure to pay in the terms and amounts indicated will give rise to the collection by coercive
jurisdiction;
c) Products' confiscation: The Instituto Nacional de Vigilancia de Medicamentos y
Alimentos, Invima, may order the confiscation of products whose sanitary conditions do not
correspond to those authorized in the respective sanitary registry, or that violate current
provisions, or that represent a danger to health.
Minutes will be drawn up from the diligence in triplicate, which will be signed by the officials
or persons involved in it. A copy of the record will be delivered to the person in whose care
the confiscated assets were found;
d) Suspension or Cancellation of Sanitary Registrations or Marketing Permits: When the
competent health authority verifies that the corresponding health registrations or marketing
permits have been issued in contravention of the provisions of the present decree,
depending on the seriousness of the violation, it will order the suspension or cancellation
thereof.
The suspension of health registrations or marketing permits will be lifted when the causes
that originated it disappear. If after six (6) months these causes have not disappeared, the
registration will be canceled;
e) Temporary or permanent closure: In the events in which it has not been possible to
obtain compliance with the provisions violated by means of a reprimand, fine, or
confiscation, a sanction of temporarily or permanently establishments' closure will be
imposed, putting an end to the activities in them developed, this may be ordered for the
entire establishment or only for a part or a process that is developed in it. The temporary
closure will subsist as long as the causes that originated it remain.
From the execution of the resolution by which the closure is imposed, no activity may
be carried out except the one necessary to avoid the deterioration of the equipment or
the conservation of the property. The closure implies that the products that are
produced, stored, and/or conditioned in the establishment cannot be sold.
Article 81. Sanctions' notification. The sanctions imposed by reasoned resolution
must be personally notified to the affected party, their legal representative, or their proxy
within a term of five (5) business days after its issuance; Against the administrative act
in question, legal resources proceed in accordance with the provisions of article 50 of
the Contentious-Administrative Code.
If the notification cannot be made in person, it must be supplied by edict in accordance
with the provisions of article 45 of the Contentious-Administrative Code.
When a sanction is imposed for a specific period, this will begin to be counted from the
execution date of the ruling that imposes it and the time elapsed under a sanitary
security measure will be computed for its purposes.
Article 82. Denaturation or deactivation. In the cases in which it is appropriate, the
health authority will proceed to denature or deactivate the inputs or products that the
present decree contemplates in accordance with the provisions of Decree 2676 of 2000
or the regulations that add, modify or replace it.
Article 83. Transfer of the diligence. When as a result of an investigation performed
by a health authority, it is found that the action is the responsibility of another authority,
the proceedings carried out for what is pertinent must be referred to it. When tests must
be performed outside the jurisdiction of the respective Territorial Directorate or the entity
that acts in its place, which is carrying out a sanctioning procedure, the director of the
same may commission the director of another directorate for its practice, in which case
the practice tests will be done in a term of two (2) months.
Article 84. Prohibition of carrying out activities due to suspension or cancellation.
From the execution of the resolution by which the respective sanitary registrations and
marketing permits suspension or cancellation is imposed, the product subject to the
measure may not be manufactured or marketed.
Article 85. Compliance with the sanction. The health authority must adopt the
pertinent measures for the execution of the sanction, such as the apposition of seals,
bands, or other appropriate systems, and may publicize the facts that derivate on risks
to the people's health as a result of non-compliance with the health provisions, for
preventing users, without prejudice to civil, criminal or other liability that may be incurred
with the violation of this regulation and other provisions that modify or add to it.
CHAPTER X
Transience
Article 86. Deadlines. After two (2) years from the effective date of the present decree,
the production or importation of controlled technology medical devices or biomedical
equipment must have the corresponding health records or marketing permits in
accordance with the provisions of the present decree.
Controlled technology biomedical equipment that is imported or manufactured during
this period and that has not obtained its import authorization, must continue to request
the respective authorization according to the provisions in force.
Laboratories, manufacturing establishments, and importers of medical devices and
controlled technology biomedical equipment that are currently protected under sanitary
registration will have the same term to adapt the labels and packaging in accordance
with the provisions of the present decree and the regulations issued on the individual.
Article 87. Adequacy. The medical devices and biomedical equipment of controlled
technology that, at the entry into force of the present decree, are being marketed
without having the respective health registration or marketing permit must comply with
the provisions of the present decree. If the term indicated in the previous article expires,
the producers, marketers, or importers of said products have not obtained their sanitary
registration or marketing permit as the case may be, they will be subject to the security
measures and the sanctions provided in this decree.
CHAPTER XI
Provisions endings
Article 88. Of the information report. The Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, will define what is related to the reports, their
content and periodicity according to the parameters of the present decree, which must
be presented by the holders of sanitary registrations and marketing permits, the
laboratories and manufacturing establishments of the products covered by the present
decree to the delegated authorities. The Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, Invima, will process and analyze the information received,
which will be used to define its surveillance and control programs.
Paragraph 1. The Instituto Nacional de Vigilancia de Medicamentos y Alimentos,
Invima, will send to the Ministry of Social Protection a consolidated manual of the
information corresponding to the reports of the controlled technology biomedical
equipment presented by the holders of the marketing permit in the formats and with the
information that the Ministry of Social Protection establishes, from the entry into force
of the present decree.
Paragraph 2. Failure to report information by marketing permit holders on controlled
technology biomedical equipment will result in the cancellation of said permit.
Article 89. Advisory group. Corresponds to the Specialized Room for Health Supplies
and Miscellaneous Products of the Review Commission of the Instituto Nacional de
Vigilancia de Medicamentos y Alimentos, Invima, will be the advisory body of the
General Directorate of Invima for the purposes of applying the present decree.
Article 90. Validity and derogations. The present decree rules from the date of its
publication and derogates all provisions that are contrary to it and especially those
contained in Decree 2092 of 1986.

Publish and comply.

Given in Bogotá, D.C., on December 26, 2005.

ALVARO URIBE VELEZ

The Minister of Social Protection,
Diego Palace Betancourt