Medical Devices & Supplies Control Section

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Medical Devices Reporting



Adverse Event is an unexpected event caused by a medical device and may affect  patient / user’s safety and could lead to serious injury or death.

Reporting medical device adverse events and incidents to NHRA is essential. Patients, users, healthcare professionals and suppliers are encouraged to report such events to enhance health and safety protection and help prevent their recurrence.

1- Adverse events and incidents associated with medical devices must be reported to NHRA by the Post-Market Officer using the Medical Devices Reporting Form. The completed form should be submitted to medical_devices@nhra.bh. For further information about the role of the Post-Market Officer, please refer to Circular No. (18) of 2022.

2- Complaints may be submitted directly to NHRA by completing the Complaint Form and sending it to medical_devices@nhra.bh, or through the Tawasul system.

3- To receive updates on the latest medical device adverse events and safety alerts worldwide, stakeholders may subscribe to updates issued by the FDA, MHRA and SFDA.

4- If a suspected falsified medical device is identified in the Bahrain market, the Falsified Medical Device Report Form must be completed and submitted to NHRA by email.

5- For further information about medical device reporting, please refer to the Medical Devices Reporting Guideline.

6- List of Post-Market Officers in Healthcare Facilities.

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