New Regulations on Medical Devices and Products in Bahrain

TDT | Manama

Email: mail@newsofbahrain.com

The Chairman of the Supreme Health Council, Lieutenant General Dr Shaikh Mohammed bin Abdullah Al Khalifa, has announced new regulations aimed at ensuring the quality of medical devices and products in Bahrain.

The decision mandates that all establishments must obtain a license from the National Health Regulatory Authority (NHRA) to market contact lenses, medical devices, and lasers used for cosmetic purposes.

Under the new regulations, all entities are required to secure a license from the NHRA, and any activity related to medical devices and products is strictly prohibited unless conducted by a licensed establishment. This move is intended to strengthen oversight and ensure that only approved products are available in the market.

Furthermore, the regulations stipulate that medical devices and products must only be used in health facilities that hold the appropriate licenses issued by the NHRA. No device or product may be manufactured, imported, or marketed in Bahrain without prior registration with the NHRA and obtaining written permission for marketing.

The decision outlines that devices and products registered in Bahrain must come from one of the following reference countries: Saudi Arabia (SFDA), the United States (FDA), Australia (TGA), Japan (PMDA), the United Kingdom (MHRA), Ireland (HPRA), Switzerland (Swissmedic), France (ANSM), and Germany (BfArM). Registration with one of these countries is required, along with payment of the applicable fees.

Establishments are also obligated to store and transport medical devices and products according to the manufacturer's instructions. Failure to comply may result in the NHRA revoking the registration of the medical device or the establishment's license.

Furthermore, the marketing and advertising of medical devices and products are prohibited without prior authorisation from the NHRA and payment of the required fees. However, low-risk home medical devices, such as digital thermometers and blood pressure monitors, are exempt from this requirement.

The marketing license for compliant medical devices and products will be valid for three years, contingent upon the payment of the total fees due.