[Emergo, UL] Brazil ANVISA Guidance for IVDs with Changed Risk Classification per RDC 830/2023

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 1st, 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.

 

 

Brazil regulatory and classification changes for IVDs | Emergo by UL

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

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