December 21, 2023
Brazil’s medical device market regulator, ANVISA announced updates to the IVD legislation as Resolution (RDC) 830/2023 (link in Portuguese). This revokes RDC 36/2015 as well as a litany of other legislative documents (Article 69).
Alignment of RDC 830/2023 with RDC 751/2022
RDC 830/2023 serves to consolidate the relevant IVD legislation as RDC 751/2022 did for medical devices and adopt the medical device regulatory provisions effective June 1, 2024.
The new legislation aligns the IVD regulatory administrative procedures with that of medical devices (RDC 751/2022): regulatory processes (notification and registro), ANVISA forms to petition for the notification and registro, review of applications, renewal of registro and modifications. Also, similar to RDC 751/2022, regulatory documents submitted, other than labeling and forms for ANVISA, can be in English, Spanish or Portuguese (Article 63).
Minor changes to IVD classification or grouping, EU definition of IVD
There were minor changes to IVD classification and grouping of IVDs into device families. Changes related to updates on the wording were made to make the classification rules clearer. The definition for IVDs adopted is the European In Vitro Diagnostic Devices Regulation definition of IVD (IVDR, 2017/746, Article 2(2)).
Technical documentation submission format
The organization of the technical dossier or dossiê técnico submission is presented in a Table (Annex II). The submission must now be organized according to IMDRF/RPS WG/N13 (Edition 3) FINAL:2019 - In Vitro Diagnostic Device Market Authorization Table of Contents (lVD MA ToC). There are six chapters.
Hints of what’s to come
There appear to be suggestions that manufacturers of IVD instruments will require INMETRO certificates. In addition, ANVISA seems to intimate greater use of technical standards as RDC 830/2023 promulgates a definition of technical standard (Article 2(XXX)).
Emergo by UL will continue to publish news on RDC 830/2023 as well as monitor developments. We expect guidance to be forthcoming. While there seems to be limited impact on the classification and grouping of IVDs there are still changes to the regulatory process for IVDs.
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