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.

Anvisa has opened Public Consultation No. 1,313/2025 to receive suggestions on the Normative Instruction that regulates the transmission and management of the UDI Brasil database, as provided for in RDC No. 591/2021. The regulation will detail the technical and operational criteria for data transmission, making it essential for companies in the sector to be prepared for the future obligation.