ANVISA Updates Hospitalar 2026 Attendees about Regulatory Reliance

By Luiz Levy, Lilian Pinheiro and Evangeline Loh

Background ABIMED meeting February 27

At the February ABIMED meeting, ANVISA Director Marcelo Mario Matos Moreira shared the Brazil medical device regulator’s interest in prioritizing the Equivalent Foreign Regulatory Authority (AREE) regulatory process (IN 290/2024). 

ANVISA reported that use of AREEs was not as high as the expected 30% of submissions. And, as a consequence, the possibility of designating other AREEs is being assessed. 

Background on Normative Instruction 290/2024

As you may recall, ANVISA published IN 290/2024 in April 2024, effective June 2024. Class III and IV devices with authorization in one of the AREEs: Australia, Canada, 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 medical device or RDC 830/2023 if IVDs as well as other documents and the device and intended use authorized in the AREE would need to be identical to what was submitted in Brazil.  However, if these conditions were met, it was expected that this would reduce ANVISA’s review time.

ANVISA shares additional reasons why they believe AREE use is low

At Hospitalar, ANVISA staff explained the reasons for low use of the AREE route: lack of knowledge about 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. One of the main issues ANVISA has identified during reliance reviews is the lack of harmonization in intended use between what was authorized by the AREE and desired in Brazil.

Another point raised was related to authorizations used in reliance requests that were granted to different legal entities within the same group. In this case, to resolve the issue, the BRH needs to provide evidence that the entities are part of the same corporate group. For example, “Manufacturer Entity A” holds the device authorization, but the BRH submits the reliance request with “Entity B” as the manufacturer.  In this case, a document must be presented proving that such companies are members of the same manufacturing group.

ANVISA slide on the administrative actions to legalize/apostille evidence of registration

The AREE route also requires legalized/apostilled document(s). ANVISA also included one slide on the administrative burdens related to legalizing/apostilling the evidence of the AREE authorization, as well as the associated expense. 

Concluding remarks

As we have reported, ANVISA is exploring additional countries/markets as AREEs once the bilateral agreements are established. 

Emergo by UL experts have experience with successful AREE submissions to ANVISA. While it doesn’t eliminate the initial ANVISA review queue we have noted benefits in reduced review time. In addition, hawse have observed that it minimizes the chance of receiving additional questions from ANVISA about clinical data and performance testing.

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