Bahrain Medical Device Registration Guidelines

Bahrain Medical Device Registration

Pre-Registration Requirements:

• Only an authorized local representative, registered with NHRA, can submit a medical device registration application on behalf of the manufacturer
• All devices must be classified according to risk (Class I, IIa, IIb, III, and IVD A-D) before application
• The authorized representative and the device will be listed on the NHRA website once registered

Document Submission Process:

• Appointments for submission are scheduled online (e.g., via Ajheza or Appointy system) and all required documents must be submitted electronically or on CD at the booked time
• Required documents include a filled registration form, technical documentation (user manuals, service manuals, catalogues), labeling/artwork, quality certificates (e.g., ISO 13485, CE, FDA), and agreements between manufacturer and representative
• Additional documents may include instructions for use, a list of markets where the device is sold, field safety notice records, and declarations of conformity or recall status

Review and Approval:

• NHRA reviews the application and supporting documents over a period of 6–8 weeks (40–80 working days)
• If the application is rejected, applicants have two more opportunities to address deficiencies before a resubmission fee is required
• Upon approval, a registration certificate is issued, valid for 1–5 years depending on the validity of the submitted quality assurance certificate

Post -Registration and Market Access:

• Only NHRA-registered devices can be purchased by healthcare institutions in Bahrain.
• Importation is a separate process from registration and must be conducted through pre-approval systems (e.g., OFOQ platform)
• The license holder must apply for renewal at least nine months before expiration and maintain up-to-date safety and performance documentation

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