Bahrain - Medical Device Regulation

Pharmaceutical Product Regulatory Office, National Health Regulatory Authority

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

Registration of all medical device is necessary.

Class I, II and III/ IVD A, B, C, D

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

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.