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 email@example.com
2- NHRA receives complaints directly by submitting “Complaint Form” at firstname.lastname@example.org , 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.
Post Market Surveillance Officer Roles and Responsibilities workshop