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Bahrain NHRA

Bahrain NHRA

Bahrain NHRA – 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:

  • 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

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:

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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