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Bahrain

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Bahrain

Medical Device Registration in Bahrain

Ministry of Health

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

Registration Process

  • 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.

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.

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

 

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