Anvisa to use analysis by foreign authorities to register medical devices

Publicado em 23/04/2024 • News • English

The Normative Instruction (IN) no. 290of April 4th of the Brazilian Health Regulatory Agency (Anvisa) established an optimized procedure for analyzing and deciding on petitions for the registration of medical devices, through the use of analyzes carried out by an Equivalent Foreign Regulatory Authority (AREE). With this measure, the agency will now be able to evaluate products that have already been approved by equivalent foreign regulatory authorities more quickly, consolidating a major step forward in the adoption of reliable regulatory mechanisms. The World Health Organization (WHO) recommends the adoption of these mechanisms to provide the population faster access to health services and technologies.

The text of the IN stipulates that, as of June 3rd this year, medical devices authorized for markets regulated by four equivalent foreign regulatory authorities (Australia, Canada, USA, and Japan) may have their analysis shortened, when asked by the requesting companies. To do this, documents must be submitted showing that the products destined for the Brazilian market have the same production characteristics, indications and intended use as approved by the recognized regulatory authority.

Mais notícias e eventos