AVNISA, Brazil's medical device regulator, updated IVD regulations to RDC 830/2023.
The new RDC, effective from June 1, 2024, is a comprehensive revision that consolidates risk classifications and regularization procedures across all IVD risk classes, rendering the previous RDC 36/2015 obsolete.
The main changes are as follows.
- Provide process (notification and registration), ANVISA forms to petition for notification and registration, application review, registration renewal and modification, labeling requirements, and submitted regulatory documents may be written in English, Spanish or Portuguese.
- There have also been some changes to IVD classification and grouping IVDs into device suites, which have been made in relation to wording updates to make classification rules clearer.
- The composition of the technical document or dosie ̂ técnico submission is shown in Annex II, and the submission must now be configured in accordance with IMDRF/RPS WG/N13 (Edition 3) FI-NAL:2019 - In vitro diagnostic device market authorization table of contents (lVDMA ToC).
Please refer to the link below for details.
Anvisa atualiza regras sobre dispositivos médicos para diagnóstico in vitro
Norma consolida e alinha regras ao cenário internacional.
www.gov.br
If you have any questions about medical device in Brazil,
Please contact us with the below.
ra@jnmglobal.net