New UDI Regulation for IVD by ANVISA in Brazil
The National Health Surveillance Agency (ANVISA) has taken a groundbreaking step with the approval of the Resolution de Diretoria Colegiada (RDC) N° 830/2023 in the field of In-vitro Diagnostics (IVD). Dated December 6, 2023, this resolution not only signifies a significant alignment with international standards but also indicates approval for the regulatory agenda for 2024-2025.
The primary objective of RDC N° 830/2023 is to consolidate relevant legislation for IVDs, similar to RDC 751/2022. This harmonization between the two regulations ensures not only a consistent implementation of standards but also facilitates adaptation to successful practices in the field of medical devices. A notable move towards internationalization is the allowance to submit almost all regulatory documents in English, similar to the provisions in RDC 751/2022. This measure not only promotes interaction with international stakeholders but also facilitates the global exchange of information and experiences.
Parallels with RDC 751/2022 are also evident in the structured organization of technical documentation for IVDs. The adherence to the IMDRF Guide for the table of contents of technical documentation (IVD version) not only provides a clearer structure but also eases compliance and evaluation for authorities and manufacturers.
The resolution introduces minor changes in the classification and grouping of IVDs, aligning with the definition of IVDs according to the European In Vitro Diagnostic Devices Regulation (IVDR, 2017/746, Article 2(2)). These refinements aim to clarify classification rules and facilitate the formation of device families.
For detailed information, you can access the original text from ANVISA: https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-830-de-6-de-dezembro-de-2023-529557724
Although the impacts on the classification and grouping of IVDs may seem limited, RDC N° 830/2023 brings about changes in the regulatory process for IVDs. To stay updated on all developments in the field of Unique Device Identification, we invite you to subscribe to our newsletter. This way, you won’t miss any crucial updates and news in this domain.
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