Medical Device Regulations Roadmap: A Guide to Registration with NHRA in Bahrain

The National Health Regulatory Authority (NHRA) is an independent regulatory body established in 2010, under Law No. 38 of 2009, of the Kingdom of Bahrain. The medical device registration process in Bahrain is regulated by the NHRA and is designed to ensure that all devices placed on the market meet international standards for safety and performance.

Authority Mission and Strategic Goals

According to the NHRA's website, its mission is "to regulate the provision of healthcare in Bahrain and ensure appropriateness, continuity, efficiency and safety in delivering health services, both in the governmental and private sector. It will be based on the best scientific evidence and healthcare best practices, in accordance to international standards". Its strategic goals include the regulation and accountability of all healthcare facilities so that they meet the required standards for licensing and the continuous monitoring of the quality of the provision of health services to ensure compliance with evidence-based practices and accreditation standards.

Key Responsibilities of the NHRA

• Issue regulations and executive decisions concerning the organization of professions and health services.
• Grant and renew licences for health professionals and healthcare facilities.
• Registration and licensing of medical devices.
• Setting the rules for drug registration and pricing, and ensure the quality of medicines and pharmaceuticals.
• Monitor, evaluate and accredit healthcare facilities.
• Approving clinical trials.

Registration Requirements and Procedures

Medical Device Registration with the National Health Regulatory Authority (NHRA) is a mandatory requirement. When it comes to the general requirements, it is mandatory to appoint an Authorized Representative and register them with NHRA, as the authorized representative is the only party allowed to submit the registration application. Furthermore, all devices must be classified according to risk (Class I, IIa, IIb, III, and IVD A-D) before application.

Document Submission Process

Appointments for submission are scheduled online and all required documents must be submitted electronically or on CD at the booked time. To ensure a smooth process, the following documents are required:

• Registration Request: A completed registration request form, available on the NHRA website.
• Technical Documents: Documents containing technical information such as service/user manuals and catalogues.
• Quality Assurance Certificate: A verified quality assurance certificate (e.g., ISO 13485, CE, FDA) and quality management system.
• Authorized Representative Agreement: An agreement between the authorized representative and the device manufacturer.
• Free Sale Certificate: A certificate issued by the appropriate regulating authority of the device's country of origin.
• Declaration of Conformity: A declaration indicating the device's class based on the risk-based classification.
• Labeling Sample: A sample of the device labeling in Arabic or English.

Review, Approval, and Market Access

The NHRA reviews the application and supporting documents over a period of 6–8 weeks (40–80 working days). Upon approval, a registration certificate is issued, valid for 1–5 years depending on the validity of the submitted quality assurance certificate. Only NHRA-registered devices can be purchased by healthcare institutions in Bahrain. It is important to note that importation is a separate process from registration and must be conducted through pre-approval systems. The license holder must apply for renewal at least nine months before expiration and maintain up-to-date safety and performance documentation.