Good Medical Manufacturing Practice Certification

Good Medical Manufacturing Practice Certification

ANVISA Resolution RDC 16: 2013 sets out the requirements for Good Medical Product Manufacturing Practice. The certification of compliance with the requirements of this regulation, by the company that manufactures medical products – regardless of the country in which it is located, is a demand for the subsequent registration of these products in ANVISA – which are classified in the highest Risk Classes, III and IV.

Currently, the Certificate of Good Manufacturing Practice Certificate is 2 years. The inspection carried out by ANVISA technicians, or by auditors of accredited entities – through the MDSAP program, is the most critical step to obtain this Certification.

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