MDR (Medical Device Regulation)

MDR Overview




Medical Devices Regulation in NHRA grants all suppliers an approval to import medical devices in the Kingdom of Bahrain based on international standards.

As medical devices represent a vast part of patient care, NHRA works to protect the public and promote quality and patient safety by setting appropriate guidelines and policies in line with international best practice, by providing a harmonized regulatory system to ensure the quality and safety of all medical devices imported, and prevent the entrance of ineffective or unsafe devices to Bahrain market. For more information about NHRA role in the Pre, On, and Post market, please scroll down.

Pre Market


First, before importing or registering medical devices, you must be registered as an authorized representative in NHRA by applying and obtaining a license to import and register medical devices.


Secondly, classify medical devices by making sure that they are listed under medical devices or other category by applying for classification.


Third, submitting an application to register medical devices to facilitate the importation process into the Kingdom of Bahrain by applying for registration of medical devices.

On Market

Controlling medical device importation at the ports of entry where importers must submit an application through Ofoq website and submitting the required documents to obtain NHRA approval before importing medical devices.

Regulating advertisements for medical devices based on Decision (48) 2020, Article (10) “It is forbidden for any person to market or advertise the medical device and product unless obtaining a license from the Authority.


Post Market

Decision (48) 2020, Article (16) intended to guide and encourage all healthcare facilities, importers, patients and professionals to the importance of reporting problems associated with medical devices, including:

Permit To Use

Field Safety Notice and Recalls

Adverse Events and complains


Medical Devices Destruction

Healthcare Facilities Inspection