Medical Devices & Supplies Control Section

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Classification



For Medical Device Classification steps, please follow the following:

1- Classification procedure must be done prior to importation or registration.

2- Not all medical devices require classification, it might be requested by importation or registration team however there is a fixed list of Medical devices that require classification.

3- To submit a classification application, kindly visit  MADAR system and follow the instructions on the site.

4- For further information regarding reference countries NHRA created list of the regulatory authorities website links and contact details for applicants reference.

5- To submit the Salon devices for classification, kindly visit the MoH site and follow the instructions.

6- List of classified products as medical devices.

7- For further information about border line products classification, please visit Classification of Medical Devices Standards - GSO 2628:2021.

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