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SFDA MD Guidance: Requirements for Clinical Trials of Medical Device

Yesterday (26-December-2022) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Requirements for Clinical Trials of Medical Devices (MDS-REQ 2)".

The purpose of this guidance is to detail and explain the requirements for conducting clinical trials of medical devices within Kingdom of Saudi Arabia (KSA).

The scope of this guidance applies to all the 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.

Some of the General Requirements are

  1. SFDA establishment license shall be obtained by any Clinical Research Organizations (CRO) conducting clinical trials within KSA.

  2. A full-time Saudi national in charge of clinical trials shall be appointed, with an appropriate academic qualification not less than a bachelor's degree, and with an experience of not less than (3) years in the field of clinical trials.

  3. SFDA import permission shall be obtained for all medical devices intended to be imported for clinical trials in accordance with the Requirements for Importation, Exportation and Shipment Clearance of Medical Devices (MDS-REQ 5).

  4. The labelling or the instructions for use shall indicate that the medical device is exclusively for use in a clinical trial, and shall adhere to the requirements referred to in “Requirements for Medical Devices Marketing Authorization (MDS-REQ 1)”.

  5. The clinical trial shall comply with the following:

− Implementing Regulations of the Law of Ethics of Research on Living Creatures.

− Declaration of Helsinki.

− The standard of good clinical practice for clinical investigation of medical devices (ISO 14155) or any other similar standard.

− The standard of good study practice for clinical performance studies of in vitro diagnostics medical devices (ISO 20916) or any other similar standard

Click this LINK to know more about the Required documents prior to conducting the clinical trial.


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