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. For more information about NHRA role in the Pre, On, and Post market, please scroll down.

**Vision Statement:**

"To be a world-class regulatory authority in the Kingdom of Bahrain, ensuring the highest standards of safety and quality in medical devices, safeguarding public health, and contributing to global excellence in healthcare."

**Mission Statement:**

"Our mission is to establish and enforce stringent regulations for medical devices in the Kingdom of Bahrain, prioritizing safety and quality above all. We are committed to:

1. **Protecting Public Health:** We will rigorously assess, monitor, and control the quality, safety, and performance of medical devices to ensure that all products available in the Kingdom meet the highest standards, reducing the risks to patients and healthcare professionals.

2. **Global Alignment:** We will actively collaborate with international regulatory bodies, harmonize our standards with global best practices, and continuously strive to elevate the Kingdom's medical device regulatory framework to meet or exceed international standards.

3. **Stakeholder Engagement:** We will engage with all stakeholders, including healthcare providers, manufacturers, and the public, to promote transparency, gather feedback, and enhance communication to achieve our common goal of safer medical devices.

4. **Capacity Building:** We will invest in the development of our staff and resources to build expertise and capabilities necessary to regulate medical devices effectively, ensuring that our regulatory processes are efficient and transparent.

5. **Innovation and Technology:** We will embrace technological advancements and innovative approaches to streamline processes, improve monitoring, and foster a dynamic regulatory environment that supports innovation while safeguarding patient safety.

6. **Education and Awareness:** We will educate and raise awareness among healthcare professionals and the public about the importance of using safe and quality medical devices, empowering them to make informed choices.

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