MDR (Medical Device Regulation)

Field Safety Notice



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 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.



7. To receive the latest Field safety notices, please fill your contact details in the form below: https://www.cognitoforms.com/NHRA1/nhrapmsalertscontactapplicationform

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