ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.

Brazil’s health authority ANVISA has released the revised 2025 edition of its Manual for the Registration of Health Products, incorporating key regulatory updates for medical device manufacturers. The manual reflects the latest changes under RDC No. 751/2022, RDC No. 848/2024, and RDC No. 556/2021, offering clear guidance on classification, technical dossiers, and grouping rules. This update is essential for any manufacturer placing medical devices on the Brazilian market.