Bahrain Medical Device Registration

Comprehensive Guide to Medical Device Registration with NHRA Bahrain: Requirements, Timeline, and Adverse Event Reporting

Regulatory Authority

Pharmaceutical Product Regulatory Office, National Health Regulatory Authority

The National Health Regulatory Authority (NHRA) is a Bahraini regulatory body established in 2010 to regulate healthcare provision and ensure safety, continuity, and efficiency in both governmental and private sectors.

It implements health regulations, licensing healthcare facilities, and licensing healthcare professionals. NHRA also handles medicine registration, pricing, clinical trial approvals, professional misconduct investigations, and disciplinary hearings for health professionals. It operates under Law No. 38 of 2009 and adheres to international standards.

Link for Regulatory Authority

https://www.nhra.bh/Departments/MDR/

Local Regulation

NHRA Law (38), Article 4-B-8: Ensure that all used Medical Devices are in line with International Quality Standards.
Law No. (38) for the year 2009: Stablishing the National Organization for the Regulation of Occupations and Health Services
Law-Legislative Decree No. (21) for the year 2015:On Private Health Facilities
Resolution No. 24 of 2021

Classification of Medical Devices

Medical Devices: Class I, II and III
IVDs: Class A, B, C and D

Listing or Registration Requirements

Full registration, Based on SFDA and CE certificate; Registration process is easier with the help of SFDA certification

Documents Required

Technical Details

e., Label of the Medical Device.
Agreement or Authorization Letter issued by the legal manufacturer
Instruction for use (IFU)
Field Safety Notice Records affecting Bahrain Market.
List of End-users in case the medical device exists in the Bahrain market.
Quality Management System Certificate (QMS) – ISO 13485 for the Physical manufacturer issued by SFDA with the address matching requirement number
Quality Assurance Certificate (QAC) If the medical device/IVD risk classification is class III/class D(IVD), an EC Design examination or an FDA registration certificate is required with minimum 1 year validity If the medical device risk classification is class II B or an active implantable medical device, manufacturing site (Physical Manufacturer) recent audit report is required.
Free Sale Certificate (FSC)
Declaration letter that includes the risk classification and the GMDN code issued by the legal manufacturer.
If the medical device contains animal tissue/medicines, a letter issued by the legal manufacturer stating that the product is free from porcine derivatives is required (Not applicable for In Vitro Diagnostic (IVD) Medical devices)

In some cases, it might be required to fulfill the classification criteria issued by NHRA Medical Devices Regulations department should be provided. If the Legal manufacturer is different than the physical manufacturer, a relationship letter between the legal and physical manufacturers issued by the legal manufacturer is required. “

Registration Timeline

6 – 8 Weeks

License Validity

Minimum 1-year up to 5 years based on the validity of the submitted QAC

Additional Comments

Registered authorised representative is required, and AR can only do the registration. Registrations can also be filed with Adliya Business Center (ABC).

Medical Devices adverse events reporting

Adverse events, unexpected occurrences linked to a medical device that may jeopardize patient/user safety and could lead to severe injury or death, necessitate prompt reporting. Reporting such incidents to the National Health Regulatory Authority (NHRA) is crucial for enhancing health and safety protection and preventing their recurrence.

Adverse events associated with a medical device should be reported to NHRA by submitting the Medical Devices Reporting Form via email at medical_devices@nhra.bh.
NHRA accepts complaints directly through the submission of the “Complaint Form” at medical_devices@nhra.bh or via the Tawasul program.
Stay informed about the latest global adverse events by becoming a member of regulatory bodies such as FDA, MHRA, and SFDA.
If encountering a falsified medical device in the Bahrain market, promptly submit the Falsified Medical Device Report Form to NHRA via email.