Medical Device Registration in
Bahrain
Ministry of Health
Regulatory Authority
National Health Regulatory Authority
Medical Device Regulation
Medical Device Regulatory Guideline (MDR)
Official Language
Arabic
Classification
Medical Device – Class I, IIa, IIb and III
IVD – Class A, B, C & D
Medical Device Registration in Bahrain
- Determine the classification of the product.
- Appoint Authorized Representative
- AR books an appointment with the “Appointy” system for submitting registration.
- AR submits documents
- NHRA reviews documents
- If approved, the license is issued.
- The product can now be marketed in the Bahrain market.
Documents Required
- Medical Device Registration Form
- Technical Details & Artwork
- Agreement or Authorization Letter of AR
- A letter stating manufacturers and authorized distributors
- IFUs
- List of countries where the device is in market
- Field Safety Notice Records
- Last Audit Report
- List of End Users (in Bahrain market)
- QMS certificate
- Quality Assurance Certificate/ Declaration of Conformity
- EC Design examination certificate or FDA registration certificate (for Class III/D devices)
- Manufacturing site audit report
- Verification Evidence
- Relationship letter (Incase of the different legal and physical manufacturers)
- Free Sales Certificate or Certificate of Foreign Govt.
- Declaration letter by the legal manufacturer for risk classification and GMDN code
*Documents may vary based of the type of product
Post-market Requirements
- Death/serious injury – within 10 working days
- Another problem not associated with High risk or Injury – within 30 working days
Legalized/Notarised Documents (if any)
FSC or Certificate of Foreign Govt.
Applicable QMS
ISO 13485
Registration Timeline
If SFDA registered – < 4 working weeks
Non-SFDA registered – 8 working weeks
Authorized Representative
Yes. Should be NHRA registered
License Validity
SFDA medical devices – 3 years
Non-SFDA – based on validity of submitted QA certificate
Special Notes
License renewals to be submitted 9 months before expiry.
Submitted documents should be in English or Arabic.