MDR (Medical Device Regulation)

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/ registration team however there is a fixed list of Medical devices that require classification.


3- Applicant must first book and appointment then submit the form on the booked date to medical_devices@nhra.bh.


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


5- Some products have specific requirement like the Biological products or devices used in Saloons were applicant can use the dedicated form and follow the same process of medical devices classification application.


6- For classifying inks used in microblading and PMU please fill ink classification form and for more information about the requirement please refer to the GuidelineFor the list of allowed colorants from the ECHA, kindly refer to the following link: https://echa.europa.eu/cosmetics-colorant


7- list of classified products as medical devices.


8- 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