Brazilian medical device regulator ANVISA has published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for market access in Brazil.
Background to RDC 741/2022 and September 2023 consultation
ANVISA announced RDC 741/2022 (August 10, 2022) to establish a resolution to leverage registrations from foreign regulatory agencies deemed equivalent to ANVISA for identical devices.
A year later, a consultation (Consulta Pública n° 1.200, September 1, 2023) was posted, describing the proposed draft normative instruction (IN).
IN 290/2024 and official legislation on AREEs
ANVISA published IN 290/2024 (April 8) which establishes, based on RDC 741/2022, the process to leverage an authorization from an Equivalent Foreign Regulatory Authority (AREE).
As a reminder, this applies only to Class III and IV medical devices and IVDs, which typically have to go through the Registro regulatory process.
IN 290/2024 defines the Equivalent Foreign Regulatory Authority (AREE) as four of the former Global Harmonization Task Force (GHTF) founding members: Australia Therapeutic Goods Administration (TGA), Health Canada, U.S. Food and Drug Administration (FDA) and Japan Ministry of Health, Labor and Welfare (MHLW). IN 290/2024 goes into force on June 3, 2024.
Brazil ANVISA Legislation Allows Leveraging Regulatory Authorizations for Medical Devices
Medical device regulator ANVISA published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for Brazil market access.
www.emergobyul.com
