In December 2023, the Brazilian National Health Surveillance Agency (ANVISA) updated the Regulation Resolução Da Diretoria Colegiada – RDC Nº 830, de 6 de dezembro de 2023 (RDC 830/2023) covering In Vitro Diagnostic (IVD) Medical Devices, bringing it closer to the one on Medical Devices Resolução Da Diretoria Colegiada – RDC Nº 751, de 2022 (RDC 751/2022) and abandoning the previous Regulation, Resolução Da Diretoria Colegiada – RDC Nº 36, de 2015 (RDC 36/2015).
ANVISA’s goal is to consolidate the regulations governing IVDs as for Medical Devices, adopting the regulatory provisions that will come into force on June 1, 2024.
Specifically, the latest revision aligns with the regulation governing Medical Devices, RDC 751/2022, on several aspects, such as:
- regulatory processes;
- ANVISA application forms for notification and register;
- review of applications;
- renewal of the register and amendments.
Furthermore, the documents to be submitted, other than the labelling and forms for ANVISA, may be drafted in English, Spanish or Portuguese, as stated in Article 63 of RDC 830/2023.
The update also concerned the classification of IVD devices and their grouping into categories, adopting the definition of IVD device given in Article 2(2) of the IVDR (EU) 2017/746.
The technical documentation must be organised according to the table in Anx.II of RDC 830/2023, which is aligned with the document issued by the Regulators Forum: IMDRF/RPS WG/N13 (Edition 3) FINAL:2019 – In Vitro Diagnostic Device Market Authorization Table of Contents (lVD MA ToC).
Finally, ANVISA attaches more importance to the use of technical standards, carefully defined in Article 2 of RDC 830/2023.
In conclusion, although the impact on classification seems to be limited, the regulatory process for IVD devices is undergoing important changes.
ANVISA demonstrates its desire to keep the regulation governing IVD devices in step with that of other countries, such as the USA and Europe, to guarantee the best technology for its users and patients.
>> Through the services of strategic-regulatory consulting Thema supports the registration with ANVISA for the marketing of Medical Devices and IVDs in Brazil.
Source
RESOLUÇÃO DA DIRETORIA COLEGIADA – RDC Nº 830, DE 6 DE DEZEMBRO DE 2023
