MDR (Medical Device Regulation)

MDR Overview


Medical Devices Regulation in NHRA grants all suppliers an approval to import medical devices in the Kingdom of Bahrain based on international standards.

As medical devices represent a vast part of patient care, NHRA works to protect the public and promote quality and patient safety by setting appropriate guidelines and policies in line with international best practice, by providing a harmonized regulatory system to ensure the quality and safety of all medical devices imported, and prevent the entrance of ineffective or unsafe devices to Bahrain market.M

Medical Device Regulatory Guideline

Pre Market

First, befor importing or rigistring medical devices, you must register as authorized representative in NHRA by applying and obtaining a license to import adn register medical devices.

Secondly, classify medical devices by make sure that they are listed under medical devices or other category by appling for classification.

Third, submitting an application to register medical devices to facilitate their import into the Kingdom of Bahrain by appling for registration of medical devices.

On Market

Monitoring customs entrances and ports for the entry of medical devices into the Kingdom of Bahrain

Importing medical devices by submitting an application through Ofoq website and submitting the required documents to obtain NHRA approval before importing medical devices.

Regulating advertisements for medical devices,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.

Permit To Use

Field Safety Notice and Recalls

Medical Devices Destruction

Healthcare Facilities Inspection