On March 20, 2024, the Agência Nacional de Vigilância Sanitária (ANVISA) officially extended the validity of Brazilian Good Manufacturing Practice (B-GMP) certificates to four years for manufacturers participating in the Medical Device Single Audit Programme (MDSAP), and this extension took effect on April 1, 2024.
Specifically, ANIVSA published Resolution RDC 850/2024 amending Article 8 of RDC 497/2021 and officially extending the B-GMP certificate from two to four years for manufacturers participating in the MDSAP programme. Naturally, the manufacturer must maintain its MDSAP certificate for the duration of the B-GMP certificate.
In addition, a manufacturer who has applied for the renewal of its B-GMP certificate but has not yet received final approval from ANVISA before Resolution 850/2024 comes into force may still benefit from the four-year B-GMP extension.
The extension of the validity of B-GMP certificates from 2 years to 4 years is a very important innovation because it further increases the benefits of MDSAP certification and reduces regulatory costs.
In addition, ANVISA announced that DRC 830/2023 will come into force on June 1, 2024, whereby it will ask manufacturers to close the gaps between DRC 36/2015 and DRC 830/2023.
Specifically, on March 25, 2024, the Brazilian regulatory authority published three guidance documents for RDC 830/2023:
- Q&A on RDC 830/2023;
- IVDs with risk classifications that have changed;
- IVDs with more than one risk classification.
Q&A on RDC 830/2023 is organised into chapters on specific topics and presents ANVISA’s answers to questions posed on RDC 830/2023. IVDs with risk classifications that have changed describes how the classification of devices has changed. Consequently, manufacturers are required to carry out classification revisions. Finally, IVDs with more than one risk classification also describes IVD devices with more than one risk class.
Manufacturers are therefore encouraged to carry out a gap assessment between RDC 36/2015 and RDC 830/2023, going, in particular, to review the classification of their IVDs.
Through the extension of B-GMP, ANVISA wants to make MDSAP certification more advantageous, to induce more manufacturers to market their devices in Brazil.
The entry into force of RDC 830/2023 demonstrates that ANVISA wants to keep the regulations governing IVD devices in step with those of other countries, such as the USA and Europe, to guarantee its users and patients the best technology.
>>> Through the services of strategic-regulatory consulting Thema supports the registration with ANVISA for the marketing of Medical Devices and IVDs in Brazil.
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