Bahrain - 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/
- 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
Contact us for free consultation: [email protected]