Brazil ANVISA Guidance for IVDs with Changed Risk Classification per RDC 830/2023

by Lilian Pinheiro, Luiz Levy, and Evangeline Loh

As previously reported by Emergo by UL, Brazilian medical device and IVD market regulator ANVISA has released three guidance documents to further clarify Resolution RDC 830/2023. Of interest to this post is the document regarding IVDs with a changed risk classification. The IVDs are presented in five tables: Class III to Class II, Class II to Class III, Class IV to III, Class II to IV, and Class III to IV.

IVDs considered Class II per RDC 36/2015 and now upclassified to Class III because of RDC 830/2023 are the largest group of IVDs with new classifications.

Changed regulatory processes for IVDs with revised risk classifications

The former regulatory process for Class I and Class II IVDs (RDC 36/2015) was referred to as Cadastro. RDC 830/2023, similar to RDC 750/2022, officially substituted Cadastro for Notificação implementing RDC 423/2020.

When there is a change in the regulatory process, from Notification to Registro, the manufacturer of the IVD must file a petition to adjust the IVD risk classification following ANVISA publication of specific requirements for the IVD to the website. This will be available from June 1^st, 2024, and manufacturers based in Brazil or Brazil Registration Holders (BRH) will be able to submit all regulatory documents to support the upclassification.

In addition, if the regulatory process changes from Registro to Notification (Class III to Class II), a petition can also be filed by ANVISA or the BRH, though no regulatory documents required.

IVDs upclassified from Class II to Class III or Class IV

Class II devices which are now Class III or Class IV require a Registro which is a different regulatory process. The BRH will have to submit the documents to be in compliance with the new risk classification and the Brazil Good Manufacturing Product (B-GMP).

For Class III or Class IV IVDs, the manufacturer must obtain a B-GMP certificate or request inclusion of the new risk class in the current B-GMP certificate. However, note that because of RDC 850/2024, manufacturers with a Medical Device Single Audit Program (MDSAP) certificate will be able to secure a B-GMP certificate valid for four years.

IVDs upclassified from Class III to Class IV or downclassified from Class IV to Class III

An application is not required for IVDs which continue to require a Registro. Hence Class III IVDs upclassified to Class IV or IVDs downclassified from Class IV to Class III, only need the classification rule information revised in the technical dossier when the manufacturer files the first change request or renews the device.

Concluding remarks

Manufacturers are encouraged to perform a gap assessment of RDC 36/2015 to RDC 830/2023 with a focus on the IVD classification rules. In addition, RDC 848/2024 on Essential Safety and Performance is now also applicable to IVDs.

Our upcoming webinar on RDC 830/2023 will provide an opportunity to discuss changes to Brazil registration requirements in further detail.