ANVISA Resolution RDC 665 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.