Regulatory Framework for Medical Devices in Bahrain: What You Need to Know

The Kingdom of Bahrain's medical device regulatory framework, overseen by the National Health Regulatory Authority (NHRA), ensures compliance with international safety and performance standards. Established in 2018, this framework aligns with regulations from global bodies such as the US FDA, UK MHRA, and Australian TGA, fostering a structured and transparent approach to medical device oversight.

Medical Device Registration: Key Requirements

Bahrain mandates all medical devices—regardless of risk classification (Class I, IIa, IIb, III, and IVD A-D)—to be registered before market entry. Only an authorized local representative can submit registration applications, and all registered devices are listed on the NHRA website.

Submission Process

• Appointments for submission are scheduled via Microsoft Bookings.
• Applications must include technical documents, product labeling, manufacturer agreements, and global market approvals (e.g., CE, FDA).
• Review timelines range from 40 to 80 working days (8-16 weeks).
• If rejected, applicants get two more attempts to meet compliance before requiring a resubmission fee.

Compliance and Market Monitoring

• All healthcare facilities are required to procure only NHRA-registered devices.
• Devices marketed for over five years in Bahrain need only local safety records; newer ones require global field safety notices.
• ISO 13485 certification for manufacturers and additional quality assurance documents (e.g., CE Mark, FDA CFG) are mandatory.

Ensuring Market Access in Bahrain

For companies looking to enter the Bahrain medical device market, understanding and complying with NHRA’s structured regulations is essential. By ensuring accurate documentation, quality assurance compliance, and effective local representation, manufacturers can streamline their approval process and successfully introduce their products into the Bahraini healthcare system.