Applicants are advised to obtain importation pre-approval before the shipment arrives at any port in the Kingdom of Bahrain. Applications must be submitted through the Customs Affairs OFOQ online system.
Please follow the steps below and review the relevant guidelines before submitting your application:
1- Applicant must ensure to meet one of the following eligibility requirements:

•  Holds a valid Commercial Registration under ISIC 4659 for the import, export and sale of medical devices

•  Holds a valid healthcare facility Commercial Registration

•  Is importing a medical device 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 importation into the kingdom of Bahrain.
3- Review the requirements specified in the Medical Device Importation Guideline, prepare the required documents and submit the importation pre-approval application through the OFOQ system.
4- Before submitting the application, ensure that the relevant quality assurance certificates have been verified by the Notified Body, as applicable.
5- If the shipment includes radioactive materials or products not intended for human or medical purposes, review and follow the applicable requirements before submitting the application.
6- Carefully review and comply with all applicable importation requirements to avoid any medical device importation violations.
7- If the application is reverted back with a request to submit a sample, complete the Medical Sample Validation Application Form and submit it to NHRA building together with the sample sealed by Customs Affairs.
8- If the imported medical device is affected by the transition from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR), refer to the MDD to MDR Transition Guideline.
9- For the importation of custom-made medical devices, follow the requirements specified in the Custom-made Medical Devices Importation Guideline.

Other References
National Bureau for Revenue (NBR) Medical devices 0% VAT list