Bahrain - Medical Device 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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