[Emergo, UL] Brazil ANVISA Legislation Allows Leveraging Regulatory Authorizations for Medical Devices

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.

 

According to the new Reliance route which started June 3, ANVISA will now rely on the decisions of authorities from other jurisdictions, but remains independent and responsible for the decisions taken. This is based on regulatory convergence, an international technical alignment movement that considers internationally recognized best practices, principles and standards in the regulatory process. Regulatory convergence facilitates the adoption of Reliance and allows leveraging regulatory authorizations since it considers and gives significant weight to the assessments carried out by other regulatory authorities to reach its conclusion.

IN 290/2024 and official legislation on AREEs

ANVISA published  IN 290/2024 April 8. Based on RDC 741/2022, it establishes the process of leveraging authorizations from an equivalent Foreign Regulatory Authority (AREE).

 

As a reminder, this applies only to Class III and IV medical devices and IVDs which would 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).

 

 

Brazil ANVISA Legislation Allows Leveraging Regulatory Authorizations for Medical Devices | Emergo by UL

Brazil ANVISA Legislation Allows Leveraging Regulatory Authorizations for Medical Devices

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