MDR (Medical Device Regulation)

Importation



                

    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.  



    NHRA Medical Devices Regulation Webinars - Module 3: Quality Certificates verification 2021 and Module 4: Medical device importation, 2021

                  

       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-Apply on OFOQ based in importation Guideline  , application can be only approved if all required documents are attached if the item imported under the controlled HS code is not for a human and or medical purposes.

       

      4- NHRA accredited "Al Bastaki Training & consultation company services" to facilitate and speed up the process of importing medical devices supplies to applicants who are facing difficulties in preparing the required documents.


      5-Before submitting the application on OFOQ system applicant must make sure that the certificates submitted are verified by the Notifying body, in some cases there are certain conditional documents that are requested by NHRA.

       

      6-For Radioactive material and Medical devices with biological substances there are additional requirements.

       

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

       

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

       

      Other references:

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


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

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