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ANVISA B-GMP Auditing requirements for Contract Manufacturers



My Australian based orthopaedic device manufacturer has just received MDSAP certification and we are looking into gaining approval in Brazil. I had some questions about the potential registration pathway of our device, and the impact of our MDSAP certification on this registration.

As far as I'm aware, an MDSAP certification can be used to expedite receiving Brazil-GMP certification, however our concern is that of our contract manufacturers that are listed as critical suppliers. Whilst our contract manufacturers were reviewed in their capacity to produce our device under our direction during the MDSAP audit we are now unsure if this is sufficient for market entry into Brazil or if our CM's will require an additional ANVISA GMP audit.

I was hoping someone could provide some information on the requirements for contract manufacturers to be audited by ANVISA when the legal manufacturer has MDSAP certification and has included those contract manufactures as critical suppliers during the MDSAP audit.

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