MDR (Medical Device Regulation)

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To register medical devices, please follow the steps below:

1.     Medical devices registration is going to be mandated by the 1st of February 2026.

2.     In order to register medical devices, applicants must be registered as medical devices authorized representatives.

3.     Before submitting medical devices registration applications, applicants should list all devices by submitting the listing form to medical_devices@nhra.bh.

4.     Medical devices registration process is done through booking an appointment and submitting the form and all required documents to medical_devices@nhra.bh at the booked date and time.

5.     For fast-track application submissions, NHRA have recognized conformity assessment body: Medspero Company.

6.  For fast-track application electronic submissions, NHRA have recognized conformity assessment body: ABC company. 

7.     Fees will be applied and notice to pay will be sent to applicants by email.

8.     Approvals will be sent to applicants by email and devices will be published on the List of registered medical devices.

 

Other resources:

·       vido icon.jpg NHRA Medical Devices registration process


QAC verification process guideline


Medical Device Labelling guideline

Medical Devices Violations guideline

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