Professional Documents
Culture Documents
• By MDD 93/42
Medical device means any instrument, apparatus, appliance,
software, material or other article, whether used alone or in
combination, with or without software to be used specifically for
diagnostic and/or therapeutic purposes, to be used for human beings
for the purpose of:
– Diagnosis, prevention, monitoring, treatment or alleviation of disease,
( e.g. Urinary catheter)
– Diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap, ( e.g. Bone cement)
– Investigation, replacement or modification of the anatomy or of a
physiological process ( e.g. Hip replacement)
– Control of conception ( e.g. Condoms)
And which does not achieve its principal intended action in or on the
human body by pharmacological, immunological or metabolic means,
but which may be assisted in its function by such means.
Medical Devices are classified as per their risk level and intended use.
Class B (Class-II a)– devices involving low to medium risk (Hypodermic Needle)
Class C (Class-II b)– Devices involving moderate to high risk (Lung ventilator)
Class D (Class-III)– Devices involving high risk. (Heart valve, implantable device)
By USFDA
Class-I (Low Risk):Elastic bandages , Examination Glove, Adult Incontinence Pad
Class –II (Medium Risk): Catheter Cannula, Dialyzer , Piston syringe , Needle,
Note: You will also see a link to device classification near the bottom of this page.
Research devices using FDA website
Use the database to search for devices similar to your device, called
predicted device
TIP: Use the most basic description of your devices to start your search. The FDA data base uses exact searched
so try both singular and plural searches. Use the search button & not go to quick search.
Review the various product description
TIP: Click on the name of devices that seems similar to your product and start reading about them
Determining your path to Compliance
TIP: Read product description very carefully. Find the product most similar to yours.
Once you have determine classification…
Class-1 Class-2 Class-3
Develop clinical trials
Register product using the Prepare a 510 (k) protocols, get approved by
FDA .Gov website. application. Some products FDA, then prepare & submit
Proper product code will require clinical data or premarket approval (PMA )to
be required. product testing. FDA.
Length for FDA review often depends on the quality of your submission! Don’t forget…..
Premarket Notification - also called PMN or 510(k).
•Class I, II, and III device intended for human use, for which a Premarket Approval
(PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from
510(k) requirements .
•Device manufacturers must notify FDA of their intent to market a medical device at
least 90 days in advance.
•Submitters must compare their device to one or more similar legally marketed
devices and make and support their substantial equivalency claims.
•This allows FDA to determine whether the device is equivalent to a device already
placed into one of the three classification categories
•Before marketing a device, each submitter must receive an order, in the form of a
letter, from FDA which finds the device to be substantially equivalent (SE) and states
that the device can be marketed in the U.S. This order "clears" the device for
commercial distribution.
Device must be registered on FDA. Gov website
To registered you will need: To registered you will need: To registered you will need:
Proof of Payment. Proof of Payment Proof of Payment
Correct FDA product Code 510 (K) number issued by PMA number issued by FDA
FDA
FDA will issue a 510 (k) number or PMA number. These numbers are required to
proceed with final registration step on FDA website.
Manufacturers requires a quality system comply
with 21 CFR part 820
FDA does not recognize ISO 13485 or ISO 9001 and does not certify quality system.
Instead FDA conducts Random Inspection for compliance with 21 CFR 820.
They do inspect class-3 device Manufacturer prior to PMA approval
It contains:
•Subpart A—General Provisions
•Subpart B—Quality System Requirements
•Subpart C—Design Controls
•Subpart D—Document Controls
•Subpart E—Purchasing Controls
•Subpart F—Identification and Traceability
•Subpart G—Production and Process Controls
•Subpart H—Acceptance Activities
•Subpart I—Nonconforming Product
•Subpart J—Corrective and Preventive Action
•Subpart K—Labeling and Packaging Control
•Subpart L—Handling, Storage, Distribution, and Installation
•Subpart M—Records
•Subpart N—Servicing
•Subpart O—Statistical Techniques
Medical Device Approval In Europe (CE Certification)
•Competent Authorities
•Notified Bodies
•Authorized Representatives
•Distributors
Competent Authorities
EU member states and their Competent Authorities each have their own
interpretations of how Directives should be carried out. Manufacturers
seeking to sell in more than one EU member state should take this into
account
•27 member states plus European Free Trade Association members (Norway,
Switzerland, Iceland and Liechtenstein)
•Population of more than 500 million people
•23 languages
Notified Bodies
Notified Bodies are authorized to audit manufacturers’ quality systems and test
/review devices for compliance with applicable EU Directives and standards.
•Pre-assessment of devices
•Issuance of certifications
EU regulators have increased their requirements for clinical data even for Class I
medical devices in recent years.
•In many cases, manufacturers must submit Clinical Evaluation Summary Reports that
verify the safety and performance of their products along with Technical Files or Design
Dossiers
Step Four
Authorized Representation
Manufacturers with no offices in the EU must appoint Authorized Representatives
(EC REPs) to interact with regulators on their behalf.
EC REP Responsibilities
•Registering your device with Competent Authorities before commercialization
•Serving as primary point of contact with all EU Competent Authorities
•Keeping a current copy of your Technical File/Design Dossier available for
inspections
by Competent Authorities
•Authorizing you to place EC REP name and address on your device labels, packaging
and instructions for use
•Handling Incident and Field Safety Corrective Action (FSCA) reporting to Competent
Authorities .
•Representing you before the European Commission in the event that your product
is
withdrawn in a member state
•Protecting the confidentiality of your product information
•Maintaining reports on clinical evaluation data for review by Competent Authorities
Step Five
Notified Body
Audit
Step Six:
Registration with Competent Authorities
Device manufacturers must register with the Competent Authority of the country
where their EC REPs are based.
Step Seven:
Declaration of Conformity and CE Marking
Post-Market Surveillance
(PMS) and Vigilance
•PMS required for all medical devices
sold in the EU
•Manufacturers are required to develop
proactive plans for PMS
•PMS plans should include reviews of market and field data,
complaints and corrective actions
•Systematic records of PMS findings must be kept
Import Registration of Medical devices in India under the
provisions of the Drugs & Cosmetic Act 1940 & Rules 1945.
India currently imports 70 per cent of its medical devices
At the federal (central or union) government level in India, medical device are
regulated by the Central Drug Standards Control Organization (CDSCO) under the
Ministry of Health and Family Welfare.
No regulations for medical devices in place prior to 2005.
The registration process for medical devices in India remains fluid, but regulators are
central/state laboratories.
Non notified devices do not require CDSCO registration, and may be imported into
For the import of medical devices in India, Registration Certificate in Form 41 and
Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act &
Rules.
Requirements of Import License (Form 10): (2-3 months)
Covering Letter
Self-attested copy of authorization letter
Form-8
Form-9
Notarized copy of Wholesale Licence or Manufacturing Licence of the Indian Agent
Copy of Registration Certificate in form-41
Documents as stated in Registration Certificate (In case of conditional certificate)
Notarized Labels of the device as per Rule 109 A of Drugs & Cosmetics Rules).
•The requirements for Re-registration of Devices are remains same as fresh Registration
requirements except requirement of hard copy of Plant Master File (PMF) and Device
Master File (DMF) provided there are no changes in the PMF and DMF, However soft
copy of PMF and DMF in the form of compact disc shall be provided along with the
application.
Changes happening to regulation of medical devices in
India
The Indian health ministry is planning significant changes to its regulatory
approach for medical devices. Revisions will include: