MDR (Medical Device Regulation)

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 adverse events/incidents to NHRA is very important. Patients, users, healthcare professionals and suppliers are all encouraged to report adverse events to improve the protection of health and safety and prevent it from being reoccurred.

1- Adverse events associated with a medical device should be reported to NHRA by submitting Medical Devices Reporting Form. at

2- NHRA receives complaints directly by submitting “Complaint Form at  , or through Tawasul program.

3- To be updated with latest Adverse Events worldwide, you can have a membership with FDA, MHRA and SFDA

4- In case of countering a falsified medical device in Bahrain market. Falsified Medical Device Report Form should be submitted to NHRA by email.

5- for more information and explanation about Medical devices Reporting, please refer to Guideline or watch Video.

6- List of post market officers in healthcare facilities.

Post Market Surveillance Officer Roles and Responsibilities workshopvido icon.jpg

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