Field safety notices are reports sent out by the manufacturer regarding certain medical device stating the action that should be taken which is either to recall it from the market or implement certain corrective action to use the medical device safely to protect patient and user’s safety.

When receiving a FSN:

1.      Applicant must first check if Bahrain Market is affected or NOT,  if not, an Official letter (Signed and Stamped) issued by the manufacturer should be provided by email at medical_devices@nhra.bh to NHRA.

2.      If Bahrain Market is affected, the FSN Form must be fully filled and submitted with end user acknowledgment by email.

3.      Required documents in the Check list must be submitted.

4.      For latest FSNs in Kingdom of Bahrain, please refer to List of Recalls and List of FSCA.

5.      To be updated with latest FSNs worldwide, you can have a membership with FDA, MHRA and SFDA

 

6.      for more information and explanation about FSN reporting please refer to NHRA Guideline or watch this video.