MDS – REQ 2

Requirements for
Clinical Trials of Medical Devices

Version Number: 4
Version Date: 22/12/2021

MDS-REQ-002-V4/21122
25 ‫ من‬1
Table of Content
Introduction ...................................................................................................................................... 3
Purpose .................................................................................................................................. 3
Scope……… ......................................................................................................................... 3
Background............................................................................................................................ 3
Requirements ................................................................................................................................... 4
Procedures ........................................................................................................................................ 5
Required Documents ........................................................................................................................ 6
Flowchart ......................................................................................................................................... 9
Annexes ......................................................................................................................................... 10
Annex (1-A): Application Form for Medical Devices ........................................................ 11
Annex (1-B): Application Form for In Vitro Diagnostic Medical Devices ......................... 15
Annex (2): Disclosure of Principal Investigator Conflict of Interests ................................. 18
Annex (3): Amendment Form ............................................................................................. 19
Annex (4): Definitions and Abbreviations .......................................................................... 20
Annex (5): List of Changes on the Previous Version .......................................................... 25

MDS-REQ-002-V4/21122
25 ‫ من‬2
Introduction
Purpose
The purpose of this document is to specify and clarify the requirements for conducting clinical trials of
medical devices within KSA.

Scope………
This document applies to contract research organization (CRO) or other parties wishing to conduct clinical
investigations of medical devices or clinical performance studies of in vitro diagnostics medical devices
within KSA.

For the purpose of this document, “clinical trial” is synonymous with “clinical investigation” and “clinical
performance study”.

Background
SFDA has issued this document in reference to Article seven of the "Medical Devices Law" issued by the
Royal Decree No. (M/54) dated 6/7/1442 H indicating that it is required to obtain SFDA approval before
commencing any of the verification procedures in accordance with the executive regulation.

MDS-REQ-002-V4/21122
25 ‫ من‬3
Requirements
General 1 SFDA establishment license shall be obtained by any Clinical Research
Organizations (CRO) conducting clinical trials within KSA.

2 SFDA approval shall be obtained before commencing any of the following:

1. Clinical Investigations of Medical Devices.
2. Clinical Performance Studies of In Vitro Diagnostics Medical
Devices

3 SFDA importation license shall be obtained for all investigational devices

intended to be imported for clinical trials.

4 The labelling or the instructions for use shall indicate that the investigational
device is exclusively for use in a clinical trial, and shall comply with the
requirements described in the SFDA’s guidance document entitled MDS –
G10 Guidance on Labeling Requirements for Medical Devices.

Regulatory 5 The clinical trial shall comply with the following:

References and − Implementing Regulations of the Law of Ethics of Research on
Standards Living Creatures.
− Declaration of Helsinki.
− The standard of good clinical practice for clinical investigation of
medical devices (ISO 14155) or any other similar standard of good
clinical practice for clinical investigation.
− The standard of good study practice for clinical performance studies
of in vitro diagnostics medical devices (ISO 20916) or any other
similar standard of good study practice for clinical performance
study.

Reporting of 6 All adverse events, adverse device effect, and device deficiencies shall be
Incidents and reported to the National Center for Medical Devices Reporting (NCMDR), in
Adverse Events accordance with SFDA’s guidance document entitled MDS – G39 Guidance
on Requirements for Reporting and investigation of Incidents and Adverse
Events of Medical Devices.

MDS-REQ-002-V4/21122
25 ‫ من‬4
Procedures
Submitting 1 Applicant can be local sponsor, authorised representative (in the case of
Documents to foreign sponsor), or Contract Research Organisation (CRO) within KSA.
SFDA
2 All required documents shall be submitted by email to MDCI@sfda.gov.sa as
follows:
1. Prior to conducting the clinical trial, as specified in section (A) of
“Required Documents”.
 In case of missing documents, SFDA will notify the applicant
within (7) days.
 Once conditions and requirements are satisfied, SFDA will
issue a “No Objection Letter” within (60) days.
 If conditions and requirements are not satisfied, SFDA will
issue an “Objection Letter”. In this case, the applicant is
entitled to lodge an objection to the decision within (30) days.
2. During the clinical trial, as specified in section (B) of “Required
Documents”.
3. After completing the clinical trial, as specified in section (C) of
“Required Documents”.
Inspection of a 3 SFDA has the right to conduct an inspection of the clinical trial without any
Clinical Trial prior notice.

Deviations of a 4 SFDA shall be notified within (5) days of any occurrence of a major deviation
Clinical Trial that could have a substantial impact on the safety or rights of subjects.

Suspension of a 5 SFDA has the right to suspend the clinical trial in case of major deviations
Clinical Trial from the approved investigational plan that would lead to a substantial impact
on the safety or rights of subjects.

Completion of a 6 SFDA shall be notified within (10) days of last patient follow-up.
Clinical Trial

MDS-REQ-002-V4/21122
25 ‫ من‬5
Required Documents
Required Documents Note
(A) Required documents prior to conducting the clinical trial
1 Application Form − See Annex (1-A)/(1-B)
2 Labelling of medical device − It shall include a clear indication that the
investigational device is intended to be used
exclusively for conducting the clinical trial.
3 Agreement between sponsor and clinical − It shall describe and acknowledge terms of
study site/principal investigator collaboration and responsibilities for the clinical
trial.
− It shall be signed and dated.
4 Agreement between sponsor and − It is required in case a CRO is contracted to perform
Contract Research Organization (CRO) one or more of the clinical trial-related duties and
functions.
− The agreement shall specify all duties and functions
delegated to the CRO.
− It shall be signed and dated.
5 Local research Ethics Committee (EC) − The EC shall be registered at the National Committee
approval letter of Bio Ethics (NCBE).
− It shall be signed and dated.
6 Clinical Investigation Plan (CIP) or − It shall be the latest version approved by the local
Clinical Study Protocol ethical committee.
7 Investigator's Brochure (IB) − It is only required for pre-market studies.
8 Informed consent − It shall be in Arabic and English.
9 Medical insurance − It is only required for interventional studies.
10 CV of principal investigator(s) and − A CV or any other qualifications containing
investigator(s) education, training and experiences.
11 Disclosure of Principal Investigator − See Annex (2)
Conflict of Interests − It shall be signed by the principal investigator.
12 Authorized representative (AR) licence − It is only required for sponsors located outside KSA.

13 CRO establishment licence − It is only required in case a CRO is contracted by the

sponsor.

MDS-REQ-002-V4/21122
25 ‫ من‬6
Note: Incomplete application will be deleted after (60) days from the date of submission unless an
acceptable justification is provided.

(B) Required documents during the clinical trial

15 Progress Report − It shall be submitted within one year from the start of
conducting a clinical trial.
16 Amendment form − See Annex (3)
− It shall be submitted within (10) days.
− It’s required in case of amendments to any
documents approved by SFDA.

17 Change of principal investigator − SFDA shall be notified with the following

documents:
1. CV of new PI.
2. Local research ethics committee approval for
PI change.
3. Document and agreements signed by the new
PI.
18 Withdrawal of local research ethics − SFDA shall be notified within (5) days of receiving
committee approval the withdrawal notice
19 Suspension or premature termination − SFDA shall be notified within:
or of a clinical trial o (5) days in case of suspension or premature
termination due to safety reasons.
o (15) days in case of reasons other than safety.
o Justification shall be provided in case of
suspension, premature termination, or resuming
after suspension.
20 Clinical trial deviations − Deviations that have a substantial impact on the
safety and rights of subjects or on the robustness and
reliability of the clinical data.
− It shall be reported within (5) days from the
occurrence of deviation.
(C) Required documents after completing the clinical trial
21 Clinical trial completion notification. − It shall be provided to SFDA within (10) days of last
patient follow-up.

MDS-REQ-002-V4/21122
25 ‫ من‬7
22 Clinical trial final report. − It shall be submitted to SFDA within 12 months after
completion of the clinical trial.

MDS-REQ-002-V4/21122
25 ‫ من‬8
Flowchart

Start

Is the sponsor
Yes located within No
KSA

Sponsor shall have an

Is the sponsor Authorized
Yes a Clinical Research No Representative AR to
Organization act on their behalf within
CRO KSA

Prior to clinical trial

Submit the required documents An SFDA s authorized
An SFDA s establishment
specified in section (A) of representative license shall
license shall be obtained
Required Documents via be obtained
email to MDCI@sfda.gov.sa

Does application SFDA issues a

SFDA issues an
No meet all conditions and Yes "No Objection
"Objection Letter"
requirements Letter"

During clinical trial

Submit the required documents
specified in section (B) of
Required Documents

At the end of clinical trial

Submit the required documents
specified in section (C) of
Required Documents

End

MDS-REQ-002-V4/21122
25 ‫ من‬9
 Annexes

MDS-REQ-002-V4/21122
25 ‫ من‬10
 Annex (1-A): Application Form for Medical Devices

Saudi Food and Drug Authority DATE RECEIVED: (For SFDA Use Only)

Medical Devices Application APPLICATION NUMBER: (For SFDA Use Only)

STUDY INFORMATION
Will the investigational device be imported
Aim of Study Type of Study
to KSA?
☐ Pre-market approval for a new
device
☐ Observational study ☐ Yes (importation license is required)
☐ Pre-market approval for new claims
☐ Interventional study ☐ No
☐ Post-market study
☐ Non-market study

Is this a first-in-human study? Is there a Data and Safety Monitoring Committee (DSMC)?

☐ No
☐ No
☐ Yes, Brief description:
☐ Yes

SPONSOR INFORMATION

Type of sponsor Type of sponsorship Type of aid

☐ Foundation
☐ Manufacturer
☐ University or ☐ Material support
☐ AR ☐ Commercial
Institution ☐ Funding support
☐ Hospital ☐ Non-commercial,
☐ Other, please ☐ Other, please specify:
☐ Independent specify:
specify:
individuals

Name of sponsor:

SFDA account: Phone: Email:

Address:

Contact person name: Contact person phone: Contact person email:

AUTHORIZED REPRESENTATIVE INFORMATION

Is the sponsor located outside KSA? ☐ No ☐ Yes, complete the following information:

Name of AR:

SFDA license: Phone: Email:

Address:

Contact person name: Contact person phone: Contact person email:

MDS-REQ-002-V4/21122
25 ‫ من‬11
 CRO INFORMATION

Is any part of the clinical study to be conducted by a Contract Research ☐ No ☐ Yes, complete the
Organization (CRO)? following information:
Name of CRO:

SFDA license: Phone: Email:

Address:

Contact person name: Contact person phone: Contact person email:

INVESTIGATIONAL DEVICE INFORMATION

Name of Investigational
Is the Investigational device authorized by SFDA?
Device
☐ Yes, Medical Device ☐ No, but registered in: ☐ Not registered
Marketing ☐ Australia anywhere.
Authorization (MDMA) ☐ Canada
license No.: ☐ Japan
☐ USA
☐ EU
☐ Other, specify:

The intended purpose of the investigational device

Device category

☐ Active implantable devices ☐ Single use devices

☐ Anesthetic and respiratory devices
☐ Dental devices
☐ Electro mechanical medical devices
☐ Hospital hardware
☐ Non-active implantable devices
☐ Ophthalmic and optical devices
☐ Reusable devices
☐ Assistive products for persons with disability
☐ Diagnostic and therapeutic radiating devices
☐ Complementary therapy devices
☐ Biologically derived devices
☐ Healthcare facility products and adaptations
☐ Laboratory equipment
☐ Other:

MDS-REQ-002-V4/21122
25 ‫ من‬12

Is the device implantable?
☐ No
☐ Yes, brief description:
☐ Is the device intended to remain
permanently in patient?
☐ No
☐ Yes
Does the device contain
or incorporate an
ancillary medicinal
substance?
☐ No
☐ Yes, name of
medicinal substance:
Clinical Investigation Plan
(CIP)
CIP number
☐ Randomized
☐ Non-randomized
Other study design:
Does this study include vulnerable subjects?
Number of subjects involved in the clinical study
in KSA:
Is the clinical study conducted in other countries?
☐ No
☐ Yes, please specify:
Number of study sites in KSA:
Will the device be used for cosmetic rather than medical
purposes?
☐ No
☐ Yes, Select:
☐ A non-corrective contact lens
☐ An implant for augmentation, fixation, or sculpting of
body parts
☐ A facial or other skin filler
☐ Equipment for liposuction
☐ Surgical laser equipment
Does the device
Does the device
incorporate tissues or Does the device incorporate
incorporate tissue, cells,
cells, or their cells or substances of
or their derivatives, of
derivatives of animal microbial origin?
human origin?
origin?
☐ No ☐ No ☐ No
☐ Yes, type of tissue, ☐ Yes, type of tissue, cell, ☐ Yes, type of microbial cells
cell, or substance: or substance: or substances:
STUDY INFORMATION
Scientific title:
Abbreviated title:
Clinical Investigation Plan information
CIP date CIP version Study start date Study completion date
Study Design
☐ Controlled study ☐ Experimental arm
☐ Open-label
☐ Parallel study ☐ Active comparator arm
☐ Single-blind
☐ Crossover study ☐ Sham comparator arm
☐ Double-blind
☐ Uncontrolled study ☐ No intervention arm
☐ No ☐ Yes
Total number of subjects involved in the clinical study:
Is the clinical study conducted in multiple sites in KSA?
☐ No
☐ Yes, a separate application shall be submitted for each
study site.
MDS-REQ-002-V4/21122
25 ‫ من‬13
 STUDY SITE IN KSA
Name:

Address:

Name of principal investigator: Email: Phone:

Name of Ethics committee (EC):

EC Address:

EC registration number at National

EC email: EC phone:
Committee of Bioethics:

DECLARATION

I, the sponsor defined in this application:

 undertake that I will comply with the Implementing Regulations of the Law of Ethics of Research on Living
Creatures.
 undertake that I will report to the National Center for Medical Devices Reporting (NCMDR) any Adverse
Device Effect, Adverse Event, or Device Deficiencies.
 undertake to notify ECs and principal investigators in case of withdrawal of SFDA’s approval, or part of
it, within five days of receiving the withdrawal notice.
 declare that SFDA has the right to inspect the study at any time without prior notification.
 declare that the information provided in this application is true and accurate.
 declare that I will maintain, if applicable, a proper safe return or disposal of investigational devices.

Name:

Position:

Date:

Signature:

MDS-REQ-002-V4/21122
25 ‫ من‬14
 Annex (1-B): Application Form for In Vitro Diagnostic Medical Devices

Saudi Food and Drug Authority

DATE RECEIVED: (For SFDA Use Only)
In Vitro Diagnostic Medical Devices
Application APPLICATION NUMBER: (For SFDA Use Only)

STUDY INFORMATION

Aim of Study Type of Study Will the IVD device be imported to KSA?

☐ Pre-market approval for a new device

☐ Pre-market approval for new claims ☐ Observational study ☐ Yes (importation license is required)
☐ Post-market study ☐ Interventional study ☐ No
☐ Non-market study

SPONSOR INFORMATION

Type of sponsor Type of sponsorship Type of aid

☐ Manufacturer ☐ Foundation
☐ AR ☐ University or Institution ☐ Commercial ☐ Material support
☐ Hospital ☐ Other, please specify: ☐ Non-commercial, ☐ Funding support
☐ Independent please specify: ☐ Other, please specify:
individuals
Name of sponsor:

SFDA account: Phone: Email:

Address:

Contact person name: Contact person phone: Contact person email:

AUTHORIZED REPRESENTATIVE INFORMATION

Is the sponsor located outside KSA? ☐ No ☐ Yes, complete the following information:

Name of AR:

SFDA license: Phone: Email:

Address:

Contact person name: Contact person phone: Contact person email:

CRO INFORMATION
Is any part of the clinical study to be conducted by a Cont ract Research ☐ No ☐ Yes, complete the
Organization (CRO)? following information:

MDS-REQ-002-V4/21122
25 ‫ من‬15
Name of CRO:

SFDA license: Phone: Email:

Address:

Contact person name: Contact person phone: Contact person email:

INVESTIGATIONAL DEVICE INFORMATION

Name of Investigational
Is the device registered at SFDA?
Device
☐ Yes, Medical Device ☐ No, but registered in: ☐ Not registered
Marketing Authorization ☐ Australia anywhere.
☐ Canada
(MDMA) license No.:
☐ Japan
☐ USA
☐ EU
☐ Other, specify:

The intended purpose of the investigational device

Device category

☐ Clinical Chemistry
☐ Instrument/Analyzer
☐ Coagulation
☐ Microbiological culture media
☐ Hematology
☐ Software IVDs
☐ Histology & Cytology
☐ Specimen receptacle
☐ Human genetics
☐ Tissue typing
☐ Immunohematology (blood banking)
☐ Other:
☐ Infectious disease

Is the device used as a companion Is the device used as a home -use Is the device used as a near-
diagnostic device? diagnostic device? patient diagnostic device?

☐ No
☐ No ☐ No
☐ Yes, name of corresponding drug
☐ Yes ☐ Yes
or biological product:

STUDY INFORMATION
Scientific title:
Clinical Study Protocol
Abbreviated title:

Clinical Study Protocol information

Study completion
Protocol number Protocol date Protocol version Study start date
date

Does this study include vulnerable subjects? ☐ No ☐ Yes

MDS-REQ-002-V4/21122
25 ‫ من‬16
 Number of subjects involved in the clinical study in
Total number of subjects involved in the clinical study:
KSA:

Is the clinical study conducted in multiple sites in

Is the clinical study conducted in other countries?
KSA?
☐ No
☐ No
☐ Yes, a separate application shall be submitted for
☐ Yes, specify:
each study site.

Number of study sites in KSA:

STUDY SITE IN KSA

Name:

Address:

Name of principal investigator: Email: Phone:

Name of Ethics committee (EC):

EC Address:

EC registration number at National

EC email: EC phone:
Committee of Bioethics:

DECLARATION

I, the sponsor defined in this application:

 undertake that I will comply with the Implementing Regulations of the Law of Ethics of Research on Living
Creatures.
 undertake that I will report to the National Center for Medical Devices Reporting (NCMDR) any Adverse
Device Effect, Adverse Event, or Device Deficiencies.
 undertake to notify ECs and principal investigators in case of withdrawal of SFDA’s approval, or part of
it, within five days of receiving the withdrawal notice.
 declare that SFDA has the right to inspect the study at any time without prior notification.
 declare that all information provided in this application is true and accurate.
 declare that I will maintain a proper safe return or disposal of investigational IVD devices.

Name:

Position:

Date:

Signature:

MDS-REQ-002-V4/21122
25 ‫ من‬17
 Annex (2): Disclosure of Principal Investigator Conflict of Interests

Title of Clinical Investigation Plan/

Clinical Study Protocol

Date received: (For SFDA use only)

Application Number: (For SFDA use only)

I disclose the following regarding any involvement in the clinical study of the submitted application:

 any significant payments of other type made from the sponsor, including but not limited to a grant to fund
ongoing research, compensation in the form of equipment, retainer for ongoing consultation, or honoraria;
 any proprietary interest in the investigational product held by the clinical investigator;
 any considerable equity interest (including but not limited to any ownership interest, stock deal, or other
financial interest) held by the clinical investigator in the sponsor of the covered study.

Details of the disclosable financial arrangements and interests are attached, along with a description of steps taken
to minimize the potential bias of clinical study results by any of the disclosed arrangements or interests.

Name of principal investigator:

Date:

Signature:

Note: In case of multicenter study, a separate form shall be filled for each principal investigator.

MDS-REQ-002-V4/21122
25 ‫ من‬18
 Annex (3): Amendment Form

Date:

Application Number:

1. The document type

where the change
occurs

2. The original statement

3. The changed statement

4. Reason for change

Note: Each change requires a separate amendment form.

MDS-REQ-002-V4/21122
25 ‫ من‬19
 Annex (4): Definitions and Abbreviations
KSA Kingdom of Saudi Arabia
SFDA Saudi Food and Drug Authority
MDS Medical Devices Sector
GHTF Global Harmonization Task Force
MDMA Medical Devices Marketing Authorization
NCBE National Committee of Bio Ethics
NCMDR National Center for Medical Devices Reporting
Adverse device effect Adverse event related to the use of an investigational medical device
(ADE) Note 1: This definition includes adverse events resulting from insufficient
or inadequate instructions for use, deployment, implantation, installation,
or operation, or any malfunction of the investigational medical device.
Note 2: This definition includes any event resulting from use error or from
intentional misuse of the investigational medical device
Adverse Events (AE) any untoward medical occurrence, unintended disease or injury, or
untoward clinical signs (including abnormal laboratory findings) in
subjects, users or other persons, whether or not related to the investigational
medical device.
Note 1: This definition includes events related to the investigational medical
device or the comparator.
Note 2: This definition includes events related to the procedures involved.
Note 3: For users or other persons, this definition is restricted to events
related to investigational medical devices.
Authorized individual or judicial or other body authorized under applicable law to
Representative (AR) consent, on behalf of a prospective subject, to the participation in the
clinical trial.
Clinical Investigations of systematic investigation in one or more human subjects, undertaken to
Medical Devices assess the safety or performance of a medical device.
Note: “Clinical trial” and “clinical study” are synonyms for “clinical
investigation”.
Clinical Investigation Plan document that state(s) the rationale, objectives, design and proposed
(CIP) analysis, methodology, monitoring, conduct and record-keeping of the
clinical investigation.
Note: The term “protocol” is synonym for “CIP”. However, protocol has
many different meanings, some not related to clinical investigation, and

MDS-REQ-002-V4/21122
25 ‫ من‬20
 these can differ from country to country. Therefore, the term CIP is used in
this International Standard.
Clinical Investigation document describing the design, execution, statistical analysis and results
Report of a clinical investigation.
Clinical Performance study undertaken to confirm the performance claims of an IVD medical
Studies of In Vitro device.
Diagnostics Medical
Devices
Clinical Study Site institution(s) or location(s) where the clinical performance study is carried
out, under the supervision of a principal investigator.
Clinical Study Protocol document that states the rationale, objectives, design, risk, proposed
analysis, methodology, monitoring, conduct and record-keeping of the
clinical performance study.
Contract Research person or organization contracted by the sponsor to perform one or more of
Organization (CRO) the sponsor's clinical trial-related duties and functions.
Deviation instance(s) of failure to follow, intentionally or unintentionally, the
requirements of the CIP.
Device Deficiency inadequacy of a medical device with respect to its identity, quality,
durability, reliability, safety or performance.
NOTE: Device deficiencies include malfunctions, use errors, and
inadequate labeling.
Endpoint(s) 〈primary〉 principal indicator(s) used for assessing the primary hypothesis
of a clinical trial.
Ethics Committee (EC) independent body whose responsibility is to review clinical trials in order
to protect the rights, safety and well-being of human subjects participating
in a clinical trial.
Note 1: For the purposes of this International Standard, “ethics committee”
is synonymous with “research ethics committee”, “independent ethics
committee” or “institutional review board”. The regulatory requirements
pertaining to ethics committees or similar institutions vary by country or
region.
Informed Consent process by which an individual is provided information and is asked to
voluntarily participate in a clinical trial.
Note: Informed consent is documented by means of a written, signed and
dated informed consent form.
Investigational Medical Medical or IVD device being assessed for safety or performance in a clinical
Device trial.

MDS-REQ-002-V4/21122
25 ‫ من‬21
 Note 1: This includes medical devices already on the market, that are being
evaluated for new intended uses, new populations, new materials or design
changes.
Note 2: In this International Standard, the terms “investigational medical
device” and “investigational device” are used interchangeably.
IVD Medical Device medical device, whether used alone or in combination, intended by the
manufacturer for the in vitro examination of specimens derived from the
human body solely or principally to provide information for diagnostic,
monitoring, or compatibility purposes
Note: IVD medical devices include reagents, calibrators, control materials,
specimen receptacles, software and related instruments or apparatus or
other articles and are used, for example, for the following test purposes:
diagnosis, aid to diagnosis, screening, monitoring, predisposition,
prognosis, prediction, determination of physiological status.
Investigator individual member of the investigation site team designated and supervised
by the principal investigator at an investigation site to perform critical
clinical trial-related procedures or to make important clinical trial-related
decisions.
Note: An individual member of the investigation site team can also be called
“sub-investigator” or “co-investigator”.
Investigator's Brochure compilation of the current clinical and non-clinical information on the
(IB) investigational medical device(s), relevant to the clinical trial.
Labelling means written, printed or graphic matter
A. Affixed to MD/IVD medical device or any of its containers or wrappers.
B. Information accompanying MD/IVD medical device, related to
identification, technical description.
C. Information accompanying MD/IVD medical device, related to
its use, but excluding shipping documents.
Medical Device means any instrument, apparatus, implement, machine, appliance, implant,
in vitro reagent or calibrator, software, material or other similar or related
article:
Intended by the manufacturer to be used, alone or in combination, for
human beings for one or more of the specific purpose(s) of:
Diagnosis, prevention, monitoring, treatment or alleviation of disease,
Diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap,
Investigation, replacement, modification, or support of the anatomy or of a
physiological process,

MDS-REQ-002-V4/21122
25 ‫ من‬22
 Supporting or sustaining life,
Control of conception,
Disinfection of medical devices,
Providing information for medical or diagnostic purposes by means of in
vitro examination of specimens derived from the human body;
And
Which does not achieve its primary intended action in or on the human body
by pharmacological, immunological or metabolic means, but which may be
assisted in its intended function by such means.
National Centre for means an organization that manage a database of information on safety
Medical Device Reporting and/or performance related aspects of medical devices and implement
(NCMDR) appropriate action on any confirmed complication.
Objective main purpose for conducting the clinical trial.
Principal Investigator (PI) qualified person responsible for conducting the clinical trial at an
investigation site
Note If a clinical trial is conducted by a team of individuals at an
investigation site, the principal investigator is responsible for leading the
team.
Serious Adverse Event adverse event that
(SAE) a) led to death,
b) led to serious deterioration in the health of the subject, that either resulted
in
a life-threatening illness or injury, or
a permanent impairment of a body structure or a body function, or
in-patient or prolonged hospitalization, or
medical or surgical intervention to prevent life-threatening illness or injury
or permanent impairment to a body structure or a body function,
c) led to foetal distress, foetal death or a congenital abnormality or birth
defect
Note: Planned hospitalization for a pre-existing condition, or a procedure
required by the CIP, without serious deterioration in health, is not
considered a serious adverse event.
Sponsor individual or organization taking responsibility and liability for the
initiation or implementation of a clinical trial.
NOTE When an investigator initiates, implements and takes full
responsibility for the clinical trial, the investigator also assumes the role of
the sponsor.

MDS-REQ-002-V4/21122
25 ‫ من‬23
Subject individual who participates in a clinical trial.
NOTE A subject can be either a healthy volunteer or a patient.
Vulnerable Subject individual whose willingness to volunteer in a clinical investigation could
be unduly influenced by the expectation, whether justified or not, of benefits
associated with participation or of retaliatory response from senior members
of a hierarchy in case of refusal to participate
example Individuals with lack of or loss of autonomy due to immaturity or
through mental disability, persons in nursing homes, children, impoverished
persons, subjects in emergency situations, ethnic minority groups, homeless
persons, nomads, refugees, and those incapable of giving informed consent.
Other vulnerable subjects include, for example, members of a group with a
hierarchical structure such as university students, subordinate hospital and
laboratory personnel, employees of the sponsor, members of the armed
forces, and persons kept in detention.

MDS-REQ-002-V4/21122
25 ‫ من‬24
 Annex (5): List of Changes on the Previous Version
Number & Date
Changes Description
of the Previous Version
3.1  Update and combine the following documents:

10/09/2020 o Guidance on Requirements for Clinical Investigations (Trials)

of Medical Devices (MDS-G20).
o Guidance on Requirements for Performance Evaluation
Studies of In Vitro Diagnostics Medical Devices (PESIVD)
(MDS-G32).
 Addition of the requirement of obtaining SFDA establishment
license for Clinical Research Organization (CRO) based on
clause (4) in the (Second Article) of “Medical Devices Law”
issued by the Royal Decree No. (M/54) dated 6/7/1442 H, and
Article No. (10/24) of “The Executive Regulation of Medical
Devices Law” issued by the SFDA Board of Directors Decision
No. (3-29-1443) dated (19/2/1443 H).
 Amendment to the scope of the document to include clinical
investigation of medical devices, and clinical performance
studies of in vitro diagnostic devices.
 Amendment to the “Requirements” section.
 Adding a "Procedures" section.
 Amendment to the “Required Documents” section.
 Amendment to the “Flowchart” according to the updated
requirements and procedures.
 Adding an application form for conducting a clinical performance
study of in vitro diagnostic devices.
 Update and modify “Definition and Abbreviations” in reference
to “Medical Devices Law” and its executive regulation.

MDS-REQ-002-V4/21122
25 ‫ من‬25