Brazil ANVISA Regulatory Reliance Leveraging Medical Device AREE Authorizations Update

By Luiz Levy, Priscila Sanada and Evangeline Loh

On April 8, ANVISA published IN 290/2024, based on RDC 741/2022, which permitted manufacturers of higher-risk devices to leverage registrations from Equivalent Foreign Regulatory Authority (AREE), provided that the devices registered with the AREEs are identical, have the same intended use and indications for use, and were not authorized under an abbreviated procedure.

The new reliance route commenced June 3, 2024, granting ANVISA authority to rely on AREE decisions.

Synopsis of IN 290/2024 

The scope of the legislation is Class III and IV medical devices and IVDs (registro regulatory process) with authorization already in one of the four AREEs: Australia Therapeutic Goods Administration (TGA), Health Canada, U.S. Food and Drug Administration (FDA) and Japan Ministry of Health, Labor and Welfare (MHLW). Technical dossier documents and other documents (for example, Essential Safety and Performance Requirements Checklist per RDC 848/2024) required by RDC 751/2022 for medical devices or RDC 36/2015 updated by RDC 830/2023 for IVDs, must still be submitted as part of the initial registration submission. 

Additional documents required for IN 290/2024: Annex I

Additional documents required for the reliance process are described in Annex I, including:

1. Signed declaration (Annex I template) by the technical manager and the legal responsible person
2. Evidence of authorization in the AREE country (consularized or apostilled) plus sworn translation if not in Portuguese, English or Spanish) and
3. IFU for medical device in AREE (plus sworn translation if not in Portuguese, English or Spanish).

The Brazil registration holder (or manufacturer in Brazil) submits an amendment after the registration submission (Article 10). 

Registro approvals tend to be up to 20% quicker

Our experience with the registro submissions through the reliance route, is that reviews, if accepted by ANVISA, are swifter.  Data collected indicates that approval times are reduced by 20%. 

In addition, our experience is that the majority of material and orthopedic registro applications, result in additional questions (additional information request) from ANVISA: this reduces the chance of receiving questions from ANVISA about clinical data and performance testing. 

AREE authorizations: end-of-year results

This is the first year of regulatory leveraging of AREE authorizations of medical devices in Brazil. The initial signs are that reliance is achieving what was intended by IN 290/2024.

The International Medical Device Regulators Forum (IMDRF) has been instrumental in regulatory convergence/regulatory reliance. This is clearly a victory in regulatory reliance – an international technical alignment movement that considers internationally recognized best practices, principles and standards in the regulatory process! As we have reported, legislation in Mexico (Agreement July 18) also demonstrates a commitment to regulatory reliance. 

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