Bahrain NHRA

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/

Local Regulation:

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:

Registration can be only done by: Registered Authorised Representative

Process of Registration:

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.

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