Official Gazette Issue No. 3781 – Thursday, 21 November 2024 Supreme Council of Health Resolution No. (69) of 2024 Amending Certain Provisions of Resolution No. (48) of 2020 Concerning the Quality Control of Medical Devices and Products The President of the Supreme Council of Health: After reviewing: Resolution No. (20) of 2016 concerning the determination of fee categories for private health institutions, as amended by Resolution No. (24) of 2021, Resolution No. (48) of 2020 concerning the quality control of medical devices and products, The proposal submitted by the Chief Executive Officer of the National Health Regulatory Authority, And after the approval of the Supreme Council of Health, The following is decided:
Article One
Article One The definition of the term "Facility" in Article (1) of Resolution No. (48) of 2020 concerning the quality control of medical devices and products, along with the provisions of Articles (3), (6), (7), (9), and (10), paragraphs one and two, shall be replaced with the following definition and provisions: Article (1): Facility: Any legal entity practicing an activity in the Kingdom related to medical devices and products, as well as laboratory and diagnostic devices and products, including their manufacturing, use, importation, marketing, distribution, storage, or representing a manufacturer in their marketing or distribution. Article (3): The provisions of this resolution shall apply to all facilities and medical devices and products that will be marketed in the Kingdom, such as contact lenses and laser devices used for non-surgical cosmetic purposes, along with their accessories. Article (6): All facilities must obtain a license from the Authority. It is prohibited to engage in any activity related to medical devices and products unless through a facility licensed by the Authority. Article (7): Medical devices and products must be used in health facilities licensed by the Authority. It is prohibited to manufacture, import, or introduce any medical device or product into the Kingdom, market it, or use it unless it has been registered with the Authority and a written marketing authorization has been obtained. Furthermore, it is prohibited to transport, store, resell, dispose of, or export such devices or products without obtaining written approval from the Authority. Article (9): All facilities must ensure the storage and transportation of medical devices and products according to the instructions specified in the manufacturer's recommendations accompanying the device or product. Failure to comply with these instructions may result in the Authority canceling the registration of the medical device or revoking the facility's license. Article (10), Paragraphs One and Two: Except for low-risk home-use medical devices and products, no person may market or advertise a medical device or product without obtaining prior authorization from the Authority and paying the prescribed fees. The marketing authorization for medical devices and products that meet global quality and safety standards shall be valid for three years after the full payment of the prescribed fees.
Article Two
Article Two: A new definition shall be added to Article (1) of Resolution No. (48) of 2020 concerning the quality control of medical devices and products, as follows: Low-Risk Home-Use Medical Devices and Products: Devices and medical supplies used outside healthcare settings, requiring no complex maintenance or prescription, such as digital thermometers and blood pressure monitors.
Article Three
Article Three: A new article numbered (7) bis shall be added to Resolution No. (48) of 2020 concerning the quality control of medical devices and products, with the following text: Article (7) bis: By way of exception to Article (7) of this Resolution, medical devices and products registered in one of the following reference countries shall also be registered in the Kingdom of Bahrain: 1. Kingdom of Saudi Arabia - Represented by the Saudi Food and Drug Authority (SFDA). 2. United States of America - Represented by the Food and Drug Administration (FDA). 3. Australia - Represented by the Therapeutic Goods Administration (TGA). 4. Japan - Represented by the Pharmaceuticals and Medical Devices Agency (PMDA). 5. United Kingdom - Represented by the Medicines and Healthcare products Regulatory Agency (MHRA). 6. Ireland - Represented by the Health Products Regulatory Authority (HPRA). 7. Switzerland - Represented by Swissmedic(Swissmedic). 8. France - Represented by the French National Agency for Medicines and Health Products Safety (ANSM). 9. Germany - Represented by the Federal Institute for Drugs and Medical Devices (BfArM). Based on the registration certificate issued by one of these countries, following the payment of the applicable fee.
Article Four
Article Four A new phrase shall be added to the end of Article (12) of Resolution No. (48) of 2020 concerning the quality control of medical devices and products, as follows: The costs of disposal or destruction shall be borne by the violator.
Article Five
Article Five The definitions of "Importer" and "Distributor" mentioned in Article (1) of Resolution No. (48) of 2020 concerning the quality control of medical devices and products shall be revoked.
Article Six
Article Six The Chief Executive Officer of the National Health Regulatory Authority shall implement the provisions of this Resolution, which shall come into effect the day following its publication in the Official Gazette. President of the Supreme Council of Health Lieutenant General Dr. Mohammed bin Abdullah AlKhalifa Issued on: 16 Jumada I 1446 AH Corresponding to: 18 November 2024 AD