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Brazil - ANVISA Implements Optimized Procedure for Evaluating Medical Devices Recognized Equivalent Foreign Regulatory Authority (AREE)

​The Brazil National Health Surveillance Agency (ANVISA) issued Normative Instruction (IN) No. 290 of 2024​ in April, and came into force from June 3, 2024, established, in accordance with the Resolution RDC No. 741, of August 10, 2022, an optimized procedure for the purposes of review and approve requests to register medical devices through the use of analyses carried out by Autoridade Reguladora Estrangeira Equivalente (AREE) [meaning: Equivalent Foreign Regulatory Authority​]​​​

This Normative Instruction does not apply to medical devices that have been authorized by AREE through an abbreviated procedure that is similar to the optimized analysis procedure adopted by ANVISA.

The registration of the products mentioned in this document follows ANVISA's regular process, as outlined in Resolution RDC No. 751 from September 15, 2022, and its updates, or in Resolution RDC No. 830 from December 6, 2023, and its updates, depending on the type of medical device. The optimized procedure explained in this document assumed that medical devices have already been approved by a recognized AREE.​​​​

For the purposes of adopting the optimized analysis procedure, the following AREE and respective proof of registration or authorization are considered:

I - Australia: Australia Therapeutic Goods Administration (TGA) - Australian Register of Therapeutic Goods (ARTG);

II - Canada: Health Canada (HC) - Medical Device License;

III - United States of America (USA): US Food and Drug Administration (US FDA) - 510(k) Clearance, Premarket Approval (PMA) or 513(f)(2) "De Novo"; and

IV - Japan: Japan Ministry of Health, Labor and Welfare (MHLW) - Pre-market approval (Shonin).​

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