Bahrain NHRA
Bahrain NHRA – Medical Device Regulation
Regulatory Authority of Bahrain: Pharmaceutical Product Regulatory Office, National Health Regulatory Authority
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 inline 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
Local Listing or Registration: Registration of all medical device is necessary.
Medical devices Classification: Class I, II and III/ IVD A, B, C, D
Documents required for registration
- Technical Details
- Artwork i.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)
- 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)
- Registration can be only done by: Registered Authorised Representative
Process of Registration:
Set an appointment with NHRA using Appointy system for submitting registration form and documents listed.
NHRA will review the application in 6-8 weeks and after verification NHRA will issue a Registration Certificate.
Validity of Certificate: minimum 1 year and up to 5 years based on the validity of
the submitted QAC.
Fees: Not implement yet
Language requirement: Arabic or English.
What We Offer?
-> Assist you with technical documentation required for registration
-> Register your medical devices
-> Keep you up to date with the Bahrain regulatory requirement.
-> Help you with translation of User Manual and Labelling
Why Choose Us?
-> Working towards client satisfaction
-> Cost effective solutions
-> Project completion before deadline.
-> Quality Regulatory affairs solutions
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