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 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 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.

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.

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

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.

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

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.

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

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.

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.

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.