Jun 10, 2015

During the 2015 Hospitalar medical technology trade show in Sao Paolo, Brazilian medical device market regulator ANVISA provided an update on its participation in the international Medical Device Single Audit Program (MDSAP).

MDSAP participating regulators—ANVISA, the US Food and Drug Administration, Health Canada and the Australian Therapeutic Goods Administration—have undertaken a pilot program to accept quality system audit reports from one another for medical device registrants applying for market authorization in their respective jurisdictions.

According to Emergo consultants attending the conference, ANVISA announced plans to request industry feedback on a new regulation that will describe how the regulator will participate in MDSAP; until the program is fully implemented in Brazil, however, registration applicants will still need to request and pay for Brazilian Good Manufacturing Practice (BGMP) certification, as well as retain third-party auditor services.

As medical device manufacturers await further details and implementation of MDSAP, some common questions about how the new program will work in Brazil have emerged:

1)If a manufacturer was audited by an auditing organization accredited by MDSAP, can the manufacturer use that audit report to avoid ANVISA inspection now?
No, because ANVISA does not currently accept MDSAP audit reports and still issues only BGMP certificates based on its own quality system inspections. MDSAP audit reports will not be accepted in lieu of ANVISA inspections until official regulation is issued. Before such regulation can be published, ANVISA must hold a public consultation, assess industry comments, draft and finalize the regulation allowing MDSAP audit reports in place of ANVISA BGMP inspection reports.

2)When will ANVISA issue a public consultation on MDSAP and finalize the regulation?
ANVISA has yet to release any official timelines pertaining to MDSAP implementation. The regulator is still in the process of drafting a public consultation on the regulation.

3)Once the new regulation is published, will manufacturers audited by MDSAP-accredited auditing organizations still have to pay ANVISA for BGMP inspection requests?
Emergo’s current understanding is that yes, ANVISA BGMP inspection fees will still apply after MDSAP implementation. We anticipate that ANVISA will accept MDSAP audit reports, review them, and then issue BGMP certificates to firms whose audit reports are positive. Manufacturers will still have to initially request and pay for BGMP certification as well as pay for MDSAP third-party auditor fees.

4)Will ANVISA accept MDSAP audit reports performed prior to the publication of the new Brazilian regulation?
Yes, Emergo estimates that ANVISA will accept audit reports from MDSAP-accredited auditors provided before the new regulation is published in Brazil. MDSAP audit reports must include BGMP requirements under RDC 16/2013 in their scope, however.


  • Stewart Eisenhart