Even three weeks after the 2024 Hospitalar conference in Brazil, it is still worth highlighting some important points raised by Marcella de Abreu, GEVIT/ANVISA Manager, during her presentation covering the RDC 830/2023 legislation for in vitro diagnostic devices. This also serves as a reminder that RDC 830/2023 now applies to IVDs and products within the scope of IVDs in Brazil.
Background on RDC 830/2023
The new RDC on IVDs, which came into force on June 1, brings changes to align the regulatory requirements with RDC 751/2022 on medical devices. In addition, the classification of some IVDs changed. Note that ANVISA published three guidance documents related to classification changes.
Examples of IVD classification changes in Brazil
- VEB (Epstein-Barr), which was previously classified as Class II, is now classified as Class IV. Hemoglobin subtype, previously classified as Class II, now is Class III.
- Neisseria, Zika, Chlamydia, Parvovirus, Plasmodium that were classified as Class III are now Class IV.
- Control devices without assigned quantitative or qualitative values (i.e., products used as external (from the laboratory's own) quality control) are now classified as Class II. The old regulation did not provide for this framework; now, these products must be regulated as “IVDs” and have a period of one year to be authorized by ANVISA.
Brazil RDC 830/2023 IVD Regulation | Emergo by UL
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Emergo by UL reports from Hospitalar 2024 on updates to new legislation for IVD devices in Brazil
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