Regulatory Reliance Authorizations: Brazil’s Revised ANVISA Process June 2026

By Luiz Levy, Lilian Pinheiro and Evangeline Loh

Background on Normative Instruction 290/2024

Normative Instruction IN 290/2024 published in April 2024, became effective June 2024, establishing a regulatory reliance route in Brazil. Class III and IV medical devices and IVDs with authorization in one of the Equivalent Foreign Regulatory Authority (AREE): Australia, Canada, the U.S., and Japan, could leverage this authorization. 

Manufacturers (or Brazil Registration Holders (BRH)) would still need to submit a technical dossier document for compliance to RDC 751/2022 if a medical device, or RDC 830/2023 for IVDs, as a normal registration request. 

Upon registration submission, the manufacturer/BRH must submit the reliance request which includes:

• Evidence of AREE authorization in compliance with IN 290/2024 requirements;
• The Instructions for Use (IFU) as authorized by the AREE; and,
• The completed reliance petition form.

As long as the device authorized by the AREE is the same as included in the ANVISA registration request, it was expected that this would reduce ANVISA’s review time.

ANVISA prioritizes AREE program, yet use of IN 290/2024 is low

In the February 2026 ABIMED meeting, the ANVISA Director shared ANVISA’s interest in prioritizing the AREE and committed to increasing this to 30% of submissions. ANVISA further explained reasons for the low use of the AREE route (Hospitalar May 2026): lack of knowledge of the regulatory requirements, uncertainty about the benefits, familiarity with the standard regulatory process and the need to qualify the Brazilian market. 

ANVISA acknowledged that the intended use authorized in the AREE country does not always align with ANVISA’s legislation and that there is a lack of harmonization in intended use between what was authorized by the AREE and desired in Brazil.

Emergo secures recent AREE authorizations with the new ANVISA process

Before now, when ANVISA received the registration request and required changes, the reliance request was rejected. Along with the reliance rejection, ANVISA would also issue a requirement, in which case the applicant had 120 calendar days to respond. Upon response, the submission would go back into the queue, and this would be reviewed typically between 1-3 months.

Emergo now has experienced cases where ANVISA has issued a letter requesting revision of a specific topic and submitting the response within 30 days via amendment and not as a regular requirement response. With this revised procedure, the application would remain with the reviewer and then be reassessed within 30 days. Emergo now has successful AREE authorizations with this amendment process. 

Concluding remarks

ANVISA has introduced an amendment process on the reliance request, which allows ANVISA to ask questions and revise information without issuing a requirement and still use the reliance request to focus on specific Brazilian requirements and accept the review performed by the AREE for clinical and performance testing. Of course, with this revised process, we expect that some of the reliance requests submitted by the market will still result in a reliance rejection, especially if ANVISA assesses that the device authorized under AREE is not the same and has a different intended use from the one submitted.  Furthermore, as we have reported, ANVISA is also exploring the inclusion of additional countries/markets as AREEs once the bilateral agreements are established. 

Emergo has experience with successful AREE submissions to ANVISA. It doesn’t eliminate the initial ANVISA review queue as applications are reviewed in chronological order, but once ANVISA receives the application to start the reliance analysis, review time is reduced. As reported before, Emergo has observed that it minimizes the chance of receiving additional questions from ANVISA about performance testing and clinical data.

Emergo experts continue to remain optimistic about regulatory reliance and the use of AREE authorizations to improve the ANVISA review time.