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.