Effective Date Nears for Brazil ANVISA IVD Regulation RDC 830/2023

By Lilian Pinheiro, Priscila Sanada, and Evangeline Loh

Brazil’s medical device regulator, ANVISA released three guidance documents on RDC 830/2023, which becomes effective June 1, 2024.

ANVISA advanced  Resolution (RDC) 830/2023 on IVDs (December 2023). RDC 830/2023 consolidates the IVD legislation, and further aligns with RDC 751/2022 on medical devices, the European In Vitro Diagnostic Devices Regulation (IVDR, 2017/746), and the International Medical Device Regulators Forum guidance.

Three guidance documents to RDC 830/2023

ANVISA released three guidance documents (March 25) to RDC 830/2023: Q&A on RDC 830/2023, IVDs with risk classifications that have changed, and IVDs with more than one risk classification.

Q&A on RDC 830/2023

Similar to RDC 751/2022, the Q&A document presents ANVISA’s responses to questions posed about RDC 830/2023. The sections are organized into chapters on specific topics.

The first question emphasizes that RDC 830/2023 is for IVDs on human samples. The Response to Question 36, reminds readers that RDC 830/2023 becomes effective on June 1, and until then, RDC 36/2015 is still applicable.

Guidance on IVDs with changed risk classifications  

The ANVISA guidance identifies common IVDs with risk classifications that have changed. This is 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. In addition, the risk applicable to the IVD is listed. IVDs that are up-classified from Class II to Class III represent the largest category.

Manufacturers must perform classification reviews, as ANVISA will not contact manufacturers about these changes. Emergo by UL Brazil as a Brazil Registration Holder (BRH) is reviewing our manufacturers’ IVD classifications for potential changes in classification

Guidance on IVDs with more than one risk classification

ANVISA has also published a guidance document on IVDs with more than one risk classification. The table includes the technical name, risk class, and registration regime (notification or registro). Not surprisingly though, there are no Class I IVDs delineated.

For example, 17-Hydroxyprogesterone, amino acids, and Anti-TSH receptor antibodies are all Class II IVDs, however, if neonatal screening is the intended purpose, the IVDs are Class III.

Concluding remarks

Manufacturers are encouraged to perform a gap assessment of RDC 36/2015 to RDC 830/2023. In particular, manufacturers need to review the classification of their IVDs. Last, RDC 848/2024 on Essential Safety and Performance also applies to IVDs.

We’ll be publishing a few more updates about RDC 830/2023, including a more detailed assessment of the changes in IVD risk classification and what manufacturers will need to do.

If you’d like more information, join us for our upcoming webinar on RDC 830/2023 830/2023.