November 7, 2023
Brazilian medical device market regulator ANVISA recently issued a public consultation regarding plans to extend validity timeframes of quality management systems (QMS) to four years for manufacturers participating in the international Medical Device Single Audit Program (MDSAP).
Medical devices marketed in Brazil must be made by a manufacturer with a Quality Management System (QMS) compliant to the Brazil Good Manufacturing Practice (B-GMP) (RDC 665/2022 and RDC 497/2021). In order to secure a Registro, manufacturers of Class III and Class IV devices must obtain a B-GMP certificate.
ANVISA uses a risk-based approach (RDC 217/2018 and RDC 678/2022) to assess whether the manufacturer would be subject to an on-site inspection or off-site desktop audit.
For manufacturers with a QMS audited by an Auditing Organization and issued a Medical Device Single Audit Program (MDSAP) certificate, the on-site inspection is waived.
B-GMP certificates are valid for two years.
Consultation in October 2023
ANVISA posted a Public Consultation (Consulta Pública n° 1.208, October 16, 2023) to extend the validity of B-GMP certificates to four years when the manufacturer presents an MDSAP certificate.
This consultation is open for 45 days. The legislation would be released as a resolution to amend RDC 497/2021, and is applicable seven days after publication in the Diário Oficial da União.
Consultation Document: Amendment to RDC 497/2021
Article 8, paragraph 1 would be revised so that the validity of B-GMP certificates based on MDSAP certificates would be extended from two years to four years. The manufacturer would need to remain part of the MDSAP program the entire time (paragraph 2).
Emergo by UL monitors developments in Brazil and globally and will share information about this amending resolution in 2024.
While a manufacturer who is interested in the MDSAP program and marketing or intends to market in Brazil can not opt out of Brazil as a jurisdiction (MDSAP FAQ Version 016 2017-08-22, Questions 49 and 95), this furthers the benefits of a MDSAP certified QMS, as the validity of the B-GMP certificate would be doubled.
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