Medical devices importation Pre-approvals is mandatory before shipment arrival at the Kingdom of Bahrain Ports, it is done through customs ofoq online system, please go through the checklist below and visit the guideline to better understand the requirements, below video can be used for additional information.  

            

 1-In order to import Medical devices, applicants must either hold a valid CR ISIC 4659 (import/export/sales of medical devices) or Healthcare Facility CR or in case of importing devices to be used for personal use.

 

2-Importation of medical devices is controlled by the list of HS code and there are several medical devices that are prohibited from being imported to the kingdom of Bahrain.

 

3-Submit your application through OFOQ by following the importation Guideline.




4-Before submitting the application on OFOQ system applicant must make sure that the certificates submitted are verified by the Notifying body.

 

5-For Radioactive material and not for a human and or medical purposes there are diffrerent requirements.

 

6-Applicants must note the requirements carefully to avoid any violation.

 

7-When the application is rejected asking for Sample submission, please submit the application form with the customs sealed sample to NHRA building.




8-MDD to MDR transition effect on importation guideline.




9-Custom-made medical devices importaion guideline.




 

Other references:

1.     Video explaining the regulation of medical devices importation and verification.




2.     List of 0% vat medical devices HS code list.