Bureau of Experts at the Council of Ministers

Official Translation Department

Law of Medical Devices and Supplies

Royal Decree No. M/54

February 18, 2021

Translation of Saudi Laws

 Law of Medical Devices and Supplies

NOTE:
The translation of Saudi laws takes the following into consideration:
• Words used in the singular form include the plural and vice versa.
• Words used in the masculine form include the feminine.
• Words used in the present tense include the present as well as the future.
• The word “person” or “persons” and their related pronouns (he, his, him, they,
their, them) refer to a natural and legal person.

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 Law of Medical Devices and Supplies

Law of Medical Devices and Supplies

Article 1
In this Law, the following words and phrases shall have the meanings assigned
thereto, unless the context requires otherwise:
Law: Law of Medical Devices and Supplies.
SFDA: Saudi Food and Drug Authority.
Board: SFDA’s Board of Directors.
Executive Director: SFDA’s Executive Director.
Regulations: Implementing Regulations of the Law.
Medical Device: Any instrument, apparatus, implement, implant, in vitro
reagent or calibrator, software, or material used for operating medical devices,
or any other similar or related article, intended to be used alone or in
combination with other devices for diagnosis, prevention, monitoring,
controlling, treatment, or alleviation of disease or injury, or for compensation for
an injury; investigation, replacement, modification, or support of the anatomy or
of a physiological process; supporting or sustaining life; controlling or assisting
conception; disinfection of medical devices; providing information for medical
or personal purposes by means of in vitro examination of specimens derived
from the human body; and does not achieve its primary intended action by
pharmacological, immunological or metabolic means, but which may be
assisted in its intended function by such means.
Medical Supply: A medical material or product used in diagnosis, treatment,
replacement, or bracing; or in disability cases or other medical uses for humans,
including medical gases.
Accessories of Medical Devices and Supplies: Any material or product
intended specifically to be used with a medical device or supply to enable it to
achieve its purpose.
Innovative Medical Device or Supply: A medical device or supply which
involves innovation in technology, use, or performance and which has not been
previously introduced to the local or international market.
Assembled Medical Device or Supply: Articles assembled in one kit to meet
user requirements, which may contain non-medical devices or supplies.
Single-use Medical Device or Supply: A disposable article intended for use
on a patient in a single medical procedure.
Radioactive Medical Material: A material that emits ionizing radiation either
by itself or when used with other medical devices or supplies for the purpose of
diagnosis and treatment.
Fraudulent Medical Device or Supply: A device or supply the identity or
source of which is deliberately altered with the intent to defraud. A medical
device or supply shall be deemed fraudulent if its components have been

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 Law of Medical Devices and Supplies

altered in a manner that compromises its safety and efficacy, or if it is packed

in counterfeit containers.
Reprocessing: Procedures implemented on a used medical device or supply
for safe reuse, such as cleansing, disinfection, sterilization, and testing and
restoration of its technical functions and safety.
User: A person, whether a professional, non-professional, or patient, who uses
a medical device or supply.
Establishment: A legal entity engaged in an activity related to medical devices
and supplies.
Manufacturer: Any national or foreign establishment the purposes of which
include designing or manufacturing medical devices or supplies for use under
its name within the Kingdom or abroad. Manufacturing shall include
refurbishing, assembling, packaging, and labelling.
Health Care Provider: Any government or private establishment that provides
health care services.
Authorized Representative: A legal person based in the Kingdom who has
written authorization from a manufacturer located outside the Kingdom to
represent it in the Kingdom with regard to the implementation of this Law and
its Regulations.
Circulation of Medical Devices and Supplies: The provision of medical
devices and supplies at no cost or for a fee, whether for distribution or use.
License: A document issued by the SFDA to engage in any of the activities
subject to this Law.
MDNR: The Medical Devices National Registry established by the SFDA.
Registration: A procedure for registering in the MDNR any medical device or
supply and any establishment that engages in any activity governed by this
Law.
Marketing Authorization: A document issued by the SFDA permitting the
circulation of a medical device or supply in the market.
Certificate of Free Sale: A document issued by the SFDA stating that a
manufacturer is registered in the Kingdom and that the medical devices and
supplies to be exported have obtained marketing authorization.
Verification of Clinical Studies: An applied research in which a medical
device or supply is used on humans to assess its safety and efficacy.
Classification System: A system approved by the SFDA to assess the safety
and the level of risk of a medical device or supply.
Quality Management System: A system approved by the SFDA to verify the
quality, effectiveness, and safety of a medical device or supply in accordance
with the latest version of the Technical Standard (ISO 13485) or its equivalent,
as provided in the Regulations.
Quality Assurance: A set of technical tests, measurements, and calibrations
approved by the SFDA to verify the safety, accuracy, and quality of medical

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 Law of Medical Devices and Supplies

imaging devices, in order to ensure the efficacy of diagnosis and treatment.

Technical Regulations: Mandatory documents issued by the SFDA for
medical devices and supplies which specify the basic standards of safety,
performance, and manufacturing and provide relevant instructions, including
terms and symbols as well as packaging and labelling requirements.
Standard Specifications: Non-mandatory documents approved by the SFDA,
including rules, guidelines, specifications of medical devices and supplies, or
production processes and methods related thereto as well as terms and
symbols, and packaging and labelling requirements.
Identifying Information: Any statement, information, or illustration printed on
a medical device or supply, including identifying information, technical
description, method of use, and manner of storage and transportation.
Technical and Clinical Standards: A set of standards that determine the
quality, effectiveness, and safe use of a radioactive material in medical
applications.
Safety Alert: A notice issued by the National Center for Medical Devices
Reporting indicating the risk associated with a medical device or supply and the
corrective action required to avoid such risk.
Field Safety Corrective Action: An action taken by the manufacturer to limit
or reduce the risks compromising the safety of a medical device or supply.
Accidents of Medical Devices and Supplies: Any defect or change in the
characteristics or performance of a medical device or supply that may directly
or indirectly cause or contribute to the death or serious injury of a user.
NCMDR: The National Center for Medical Devices Reporting.

Article 2
The following activities shall be subject to the provisions of this Law:
1. Designing and manufacturing medical devices and supplies.
2. Importing, marketing, distributing, and storing medical devices and supplies.
3. Providing services to verify the conformity of medical devices and supplies
with the technical regulations and the Quality Management System, and to
verify quality assurance.
4. Verifying clinical studies.
5. Providing technical consultation services in the field of medical devices and
supplies.
6. Providing inspection services of medical devices and supplies to ensure their
conformity with the technical regulations and standards.
7. Providing maintenance services for medical devices and supplies.
8. Representing a manufacturer located outside the Kingdom.

Article 3
Under this Law, accessories of medical devices and supplies and assembled
medical devices and supplies shall be deemed medical devices and supplies.

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 Law of Medical Devices and Supplies

Article 4
Without prejudice to the powers of the Nuclear and Radiological Regulatory
Commission (NRRC) to issue licenses for engaging in activities related to the
use of radioactive medical materials, the technical and clinical specifications of
such materials must be approved by the SFDA prior to obtaining the NRCC’s
license.

Article 5
Application of this Law shall not prejudice the powers of the NRRC to issue
licenses for protection against ionizing radiation emitted by medical devices.

Article 6
Subject to Article 4 of this Law, an establishment may not engage in any of the
activities subject to this Law unless registered and a license is obtained; as for
manufacturers, an industrial license must be obtained from the competent
agency.

Article 7
An entity licensed to verify clinical studies shall, prior to conducting any
verification procedure, obtain the SFDA’s approval in accordance with the
Regulations.

Article 8
Medical devices or supplies may not be circulated unless registered and a
marketing authorization is obtained. The SFDA may exempt certain medical
devices and supplies from the marketing authorization requirement upon
verifying, in accordance with rules approved by the Board, that they are safe
and are not intended to be used for commercial purposes.

Article 9
The SFDA may, in accordance with the Regulations, exempt innovative medical
devices or supplies from certain conditions and procedures required to obtain
a marketing authorization, provided the exemption does not compromise their
safety when used.

Article 10
The Regulations shall specify the conditions and procedures necessary for
registration; issuance of the marketing authorization; and for license issuance,
renewal, amendment, transfer, and revocation.

Article 11
Imported medical devices and supplies may not be cleared unless approved by
the SFDA.

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 Law of Medical Devices and Supplies

Article 12
The Regulations shall determine the conditions for issuing a certificate of free
sale.

Article 13
The SFDA may, pursuant to a medical report, permit the entry of personal-use
medical devices and supplies in limited quantities, provided they are not used
for commercial purposes.

Article 14
Any person who dispenses or sells fraudulent, unregistered, or unauthorized
medical devices or supplies shall, upon knowledge thereof, notify the SFDA of
any information relating to the dispensed or sold devices or supplies and their
quantity, as well as the name and address of any person to whom the medical
devices or supplies are dispensed or sold, and shall refund the buyer.

Article 15
Subject to the provisions of the Commercial Agencies Law, a manufacturer who
is located outside the Kingdom and who wishes to circulate his products in the
Kingdom shall appoint an authorized representative. The Regulations shall
determine the requirements the representative must satisfy as well as the
obligations and responsibilities of the two parties.

Article 16
The manufacturer shall provide after-sale services for its medical devices and
supplies and shall comply with the provisions of this Law and its Regulations.

Article 17
Establishments shall provide the identifying information to be placed on medical
devices and supplies. The Regulations shall determine such information.

Article 18
A health care provider shall not deal with any establishment which engages in
any activity governed by this Law, unless it is registered and licensed to engage
in such activity.

Article 19
Single-use medical devices or supplies may not be reprocessed.

Article 20
Used medical devices or supplies may not be destroyed, reprocessed,
refurbished, resold, loaned, or donated except as specified by the Regulations.

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 Law of Medical Devices and Supplies

Article 21
The manufacturer shall classify medical devices and supplies in accordance
with the Classification System.

Article 22
Establishments seeking to circulate medical devices and supplies in the
Kingdom shall adhere to the Quality Management System.

Article 23
Medical devices or supplies categorized as high risk under the Classification
System may not be dispensed for use outside the facility of the health care
provider without prescription. The SFDA shall issue a list of such medical
devices and supplies.

Article 24
Medical devices and supplies may not be advertised nor promoted without the
SFDA’s approval. Advertisement and promotion shall be in accordance with the
conditions determined by the Regulations.

Article 25
Awareness and charitable campaigns, and the like, relating to medical devices
and supplies may not be organized without the SFDA's approval. Such
campaigns shall be in accordance with the conditions determined by the
Regulations.

Article 26
The SFDA shall monitor the compliance of health care providers with technical
regulations within health care facilities in order to ensure the safety and efficacy
of medical devices and supplies in diagnosis and treatment.

Article 27
An establishment or an authorized representative shall provide the SFDA with
the documents or information required thereby in accordance with this Law and
its Regulations.

Article 28
The manufacturer, authorized representative, and health care provider shall
report to the NCMDR any adverse event relating to their medical devices and
supplies.

Article 29
The NCMDR shall issue a safety alert to warn users and health care providers

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 Law of Medical Devices and Supplies

of any risks arising from the use of medical devices and supplies.

Article 30
The manufacturer and the authorized representative shall, in relation to their
medical devices and supplies, report the following to the NCMDR:
1. Safety alerts issued by similar regulatory authorities outside the Kingdom.
2. Risks compromising the safety of the medical device or supply.
3. Completion of the Field Safety Corrective Action.

Article 31
An establishment and a health care provider shall, in the event of a safety alert,
suspend the circulation of medical devices and supplies pending a notification
by the NCMDR indicating that the Field Safety Corrective Action has been
completed.

Article 32
An establishment or an authorized representative shall, if requested by the
SFDA, track medical devices and supplies in accordance with the Regulations.

Article 33
The SFDA shall be in charge of inspecting establishments and medical devices
and supplies to ensure application of the Law, the Regulations, and the
technical regulations. Inspection shall be carried out by inspectors who are
appointed pursuant to a decision by the chairman of the Board; they shall be
deemed preliminary criminal investigation officers with the power to:
1. detect and report medical devices and supplies in violation of this Law; and
2. take the following actions regarding the items in violation of this Law:
a) seize said items and related documents, if necessary;
b) collect samples for analysis; and
c) recommend the destruction of items proven to be fraudulent or harmful.
Destruction shall, pursuant to a decision by the SFDA and following standard
technical procedures, be carried out by a committee, or more, formed for such
purpose pursuant to a decision by the chairman of the Board. The violator shall
incur destruction costs.

Article 34
Any person subject to this Law shall maintain the confidentiality of information
he becomes privy to by virtue of his duties.

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 Law of Medical Devices and Supplies

Article 35
An inspector shall show his credentials upon performing his inspection duties,
and the establishment shall cooperate with him.

Article 36
SFDA inspectors may, pursuant to a decision issued by the Executive Director,
be financially rewarded for performing their duties.

Article 37
A reward not exceeding 25% of the fine may, pursuant to a decision issued by
the Executive Director, be awarded to any person, other than SFDA inspectors,
who aids in detecting any violation of the provisions of this Law and the
Regulations.

Article 38
The SFDA shall, in coordination with the Ministry of Finance, set the rules
governing the rewards referred to in Articles 36 and 37 of this Law.

Article 39
The SFDA may take the necessary precautionary measures if it suspects any
harm, misleading claim, or compromise to the safety and efficacy of medical
devices and supplies, as determined by the Regulations.

Article 40
Medical devices and supplies may not be circulated if the SFDA decides to
withdraw the same from the market or prohibit circulation thereof.

Article 41
A person shall be deemed in violation of this Law if he:
1. defrauds or attempts to defraud with regard to medical devices or supplies;
2. knowingly sells or dispenses fraudulent medical devices or supplies or
possesses the same for the purpose of trading;
3. brings, or attempts to bring, into the Kingdom medical devices or supplies
that are unregistered, fraudulent, or unauthorized for marketing;
4. manufactures medical devices or supplies in violation of this Law, the
Regulations, and the technical regulations;
5. affixes false information on medical devices and supplies or uses such
information for the promotion thereof;
6. transports or stores medical devices or supplies in violation of the SFDA's
transportation and storage requirements;
7. brings or attempts to bring into the Kingdom containers or labels of medical

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devices or supplies with the intent to defraud;

8. manufactures, prints, possesses, sells, or displays containers or labels of
medical devices or supplies with the intent to defraud; or
9. commits any other violation of this Law.

Article 42
1. Without prejudice to any harsher penalty provided for in any other law, any
person who commits any violation of this Law or the Regulations shall be
subject to one or more of the following penalties:
a) A fine not exceeding five million riyals.
b) Temporary closure of the establishment for a period not exceeding 180
days.
c) Suspension of the marketing authorization of medical devices and
supplies subject of the violation for a period not exceeding one year.
d) Revocation of the marketing authorization of medical devices and supplies
subject of the violation.
e) Preventing the violator from engaging in any activity related to medical
devices and supplies for a period not exceeding 180 days.
f) Revocation of the license.
g) The penalty imposed pursuant to sub-paragraphs (a), (b), (c), and (e) of
this paragraph may be doubled if the violation is repeated. A violation shall
be deemed a repeated violation if it is committed within one year from the
date the first violation is committed.
2. A person who commits any of the acts stipulated in Article 41(1, 2, 3, 7 and
8) of this Law shall be subject to imprisonment for a period not exceeding
ten years, a fine not exceeding ten million riyals, or both. In addition to said
penalties, the penalties stipulated in paragraph (1) (b, c, d, e, and f) of this
Article may be imposed. The penalty shall be doubled if the violation is
repeated.

Article 43
The SFDA shall impose the penalties stipulated in Article 42(1) of this Law,
according to the classification of violations and penalties approved by the
Board, taking into account the nature of the activity and the gravity of the
violation on a case-by-case basis as well as the aggravating and mitigating
circumstances of each violation. The imposition of penalties shall be approved
pursuant to a decision issued by the Executive Director or his designee. In all
cases, the SFDA may take necessary precautionary measures.

Article 44
1. A committee, or more, composed of at least three members, including at
least one legal counselor, shall, pursuant to a Board decision, be formed to
review appeals filed with the SFDA against penalty decisions issued in

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accordance with Article 42(1) of this Law.

2. Committee work procedures and remuneration of its members shall be
determined pursuant to a Board decision.
3. Committee decisions may be appealed before the administrative court.

Article 45
If the violation is subject to Article 42(2) of this Law, it shall be referred to the
Public Prosecution for investigation and to the competent court in accordance
with statutory procedures.

Article 46
A judgment or penalty decision, as the case may be, may include a provision
to publish its ruling at the expense of the violator in a local newspaper published
in the area of his residence, or, if none is available, in a newspaper published
in the nearest area or through any other appropriate medium, depending on the
type, gravity, and impact of the violation, provided that the publication is made
after the judgment becomes final, the decision becomes unappealable due to
the expiration of the period of appeal, or the issuance of a final judgment
dismissing the appeal.

Article 47
A person who sustains damage arising from a violation of this Law may file a
claim for compensation before the competent court.

Article 48
The Board shall issue the Regulations within 180 days from the date of
publication of this Law in the Official Gazette; the Regulations shall enter into
force on the date this Law enters into force.

Article 49
This Law shall enter into force 180 days following the date of its publication in
the Official Gazette.

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