ANVISA Selects Priority Foreign Authorities to Strengthen Regulatory Confidence

Medical device regulatory process accelerated by regulatory trust

Impact for Medical Device and Drug Manufacturers The National Health Surveillance Agency (ANVISA) approved, at a meeting of the Committee for Strategic Management, Risks and Institutional Innovation (CGE), the list of priority Foreign Regulatory Authorities. This decision aims to consolidate regulatory trust (“reliance”), accelerating registration and inspection processes of medicines and medical devices in Brazil. […]

QR Group Explains Anvisa’s New Rules for Importing Medical Device Components

ANVISA update on the import and storage of medical device components – RDC 860/2024 and 939/2024

Understand how the updates to RDCs 860/2024 and 939/2024 impact the import and storage of medical device components and accessories in Brazil Anvisa has updated the processes and flows related to the import and storage of medical device components. With the recent publication of Collegiate Board Resolutions (RDCs) 860/2024 and 939/2024, importers need to understand […]