2.1 In addition to the provisions stated in the Law regarding aspects of activity, the provisions of the Law and its Regulation shall apply to the following establishments, devices and products:

• First: The Following Establishments:

  • A. Establishments practice electronic activities subject to the provisions of the Law and its Regulation.

  • B. Establishments for import and export of Radioactive Medical Materials, medical imaging materials, or particle accelerators used in the formation of radioactive isotopes for medical applications.

  • C. Establishments for exporting medical devices.

• Second: The Following Devices and Products:

  • A. Combination products.

  • B. Cosmetic devices and products that have medical applications, and SFDA shall publish an updated list of such devices and products.

  • C. Cosmetic contact lenses.

  • D. Particle accelerators used in the formation of radioactive isotopes for medical applications.

  • E. Non-genetically modified bioproducts of human origin.

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• 3.1 The SFDA shall issue and publish on the SFDA's website the necessary requirements for medical device procedure packs.

• 4.1 Establishments and / or applicants involved in importing or re-exporting radioactive medical materials shall fulfill the SFDA's requirements for importing and re-exporting such materials used in medical applications, with these requirements being published on the SFDA's website.

• 4.2 The SFDA shall issue the approval or refusal of the technical and clinical specifications within ten (10) days of the SFDA's receipt of the application for importing or re-exporting radioactive medical materials.

• 4.3 Applicants for importing particle accelerators used in the formation of radioactive isotopes for medical applications shall fulfill the SFDA's requirements published on the SFDA's website.

• 5.1 The SFDA shall issue Marketing Authorization Certificates for radiation-emitting medical devices.

• 5.2 Radiation-emitting medical devices may be circulated only after obtaining a Marketing Authorization Certificate issued by the SFDA.

• 5.3 SFDA shall monitor the compliance of the Radiology, Nuclear Medicine and Radiotherapy Departments of healthcare providers to the SFDA's requirements for the safe use of medical devices published on the SFDA's website.

• 5.4 SFDA shall monitor the compliance of healthcare providers with the technical and clinical specifications for radioactive medical materials within healthcare facilities, and refer violations to the NRRC.

• 6.1 SFDA shall issue a special registration number for each establishment subject to the provisions of the Law and its Regulation.

• 6.2 Establishments practicing any of the aspects of activity subject to the provisions of the Law shall obtain a license for the establishment, its branches and warehouses from SFDA in accordance with the conditions and requirements set forth herein.

• 7.1 The SFDA will issue the approval to conduct the following:

  • 1. Clinical trial/ investigation for medical devices.

  • 2. Clinical Performance studies for in vitro and diagnostic devices.

• 7.2 Applicants seeking approval to conduct clinical trials shall provide the following information prior to initiation:

  • 1. The approved Clinical Investigation Plan (CIP).

  • 2. The approval of the Institutional Review Board (Ethics Committee).

  • 3. Information on investigators.

  • 4. The clinical trial agreement between the clinical trial Sponsor and the Contract Research Organisation (CRO).

  • 5. The clinical trial agreement between the Manufacturer and the Sponsor, if the Sponsor is not the manufacturer.

  • 6. Technical documentation which meets the essential principles and any other requirements specified by this regulation.

  • 7. Fulfilment of any / all other requirements specified by the SFDA and published on the SFDA's website.

• 7.3 A full-time Saudi national responsible for clinical trials shall be appointed, with an appropriate academic qualification of no less than a bachelor's degree, and experience in the field of clinical trials of not less than three (3) years.

• 7.4 The clinical trial of medical devices shall meet the requirements published on the website and comply with the Saudi Arabia Law on Ethics of Research on Living Creatures.

• 7.5 The SFDA shall:

  • 1. Review requests to conduct clinical trials and grant approval, if the requirements are met, no later than sixty (60) days from the date of fulfilling the requirements.

  • 2. Conduct visits to the clinical trial sites to ensure compliance with the implementation of the study, as approved.

  • 3. Grant an Import Permit for medical devices and other products needed to conduct a clinical trial.

• 7.6 The entities authorized by the SFDA to conduct clinical trials shall notify the SFDA of:

  • 1. The completion of clinical trials.

  • 2. Major deviations from the plan of the trial.

  • 3. Any occurrence that affects safety or breaches the rights of the persons subject to the study. The SFDA must be notified within five (5) days of any / all of the above, and no later.

• 7.7 The SFDA may stop a clinical trial if it is proven that: • a breach has occurred in the approved plan of the clinical trial; or • an issue has arisen that may affect the safety of the participants.

• 7.8 The manager of the Contract Research Organization (CRO) shall be a full-time Saudi national holding a bachelor's degree, as a minimum, in one of the health or scientific disciplines related to medical devices.

• 8.1 No medical device shall be circulated in the Kingdom without being scientifically assessed by the SFDA, in accordance with the requirements for Medical Devices Marketing Authorization (MDMA), published on the SFDA's website to ensure its safety and security, and obtaining Marketing Authorization.

• 8.2 After obtaining the marketing authorization, the medical devices shall be listed in the National Registry, and the same shall be deemed a registration thereof.

• 8.3

  • First: The SFDA may exclude some medical devices from the necessity of obtaining Marketing Authorization for humanitarian and research purposes, after ensuring their safety according to the following rules:

    • A. Public emergencies such as natural disasters, wars, or epidemics.

    • B. Personal use in accordance with the conditions set forth in Article (13.2) of the Regulation.

    • C. Research or educational uses.

    • D. Pre-marketing clinical trials that obtained the SFDA's approval for the clinical trial.

    • E. If they are custom-made for a specific patient, at the request of the treatment team.

    • F. Samples of medical devices used in exhibitions, festivals or workshops.

• Second: An import permit shall be obtained from the SFDA for the medical devices mentioned in Clause (First), in accordance with the requirements for importing, exporting, and clearing medical devices published on the SFDA's website.

• 9.1 A medical device shall be deemed innovative if the following conditions are met:

  • • It is designed with innovative characteristics / features, (technology / methods of use / performance characteristics), and there are no similar technologies in the local and international market.

  • • It has a clinical / medical benefit that exceeds the available alternatives.

  • • Any other conditions set by the SFDA and published on the SFDA's website.

• 9.2 The applicant shall provide the necessary information to prove the conformity of the innovative medical device with Article (9.1) in accordance with the requirements for Medical Devices Marketing Authorization, published on the SFDA's website.

• 9.3 The SFDA has the right to request further information from the applicant before making the final decision on whether to consider the medical device innovative.

• 9.4 Innovative medical devices shall be excluded from some of the requirements and procedures required to obtain Marketing Authorization based on the type and technology used, as determined by the requirements of innovative medical devices published on the SFDA's website. The SFDA has the right to exclude from the following requirements:

  • - Verification and validation of the product, including clinical trials.

  • - Periodic safety update reports and Post-Market Surveillance reports.

  • - Detailed information on design and manufacturing.

• 9.5 The applicant shall conduct clinical trials in accordance with the requirements of medical device clinical trials, if requested by the SFDA.

• 9.6 SFDA shall determine and update the requirements for innovative medical devices in accordance with the technical development.