Overview

ANVISA has recently published Normative Instruction (IN) 290/2024, outlining an optimized procedure for analyzing and deciding petitions for the registration of medical devices. This directive, effective from 06/03/2024, applies to high and maximum risk medical devices that have already obtained regularization from at least one of the four equivalent foreign regulatory authorities (AREE): Australia, Canada, the USA, and Japan.

Equivalent Foreign Regulatory Authority

The term "Equivalent Foreign Regulatory Authority" (AREE) refers to foreign regulatory bodies or international entities whose practices align with those of ANVISA. These entities ensure that authorized products have undergone appropriate evaluation and comply with recognized standards of quality, safety, and efficacy. ANVISA recognizes them as regulatory entities deserving of trust.

Optimized Analysis Procedure

The optimized analysis procedure is a technical assessment mechanism at ANVISA, facilitated by regulatory trust practices. It utilizes technical analyses or instructional documentation issued by an Equivalent Foreign Regulatory Authority as the sole or supplementary reference.

In practical terms, this means that ANVISA may forego re-evaluating efficacy and safety documents, such as test reports and clinical data, if the product has already been approved in one of the AREE countries. This streamlines the analysis and approval process for registration in Brazil.

Application of IN 290/2024

IN 290/2024 applies to medical devices (as per RDC 751/2022) and products for In Vitro Diagnostics (as per RDC 830/2023) classified in risk classes III and IV, which are currently subject to registration with ANVISA. It is important to note that the product must be essentially identical to the one intended for registration in Brazil and must be in the primary petition phase (initial registration).

Submission Requirements

To adhere to the optimized analysis procedure, companies must submit registration processes as usual, including all required documentation according to RDC 751/2022 or RDC 830/2023. Additional documentation must be filed through a separate request (addendum), following the guidelines provided in the IN.

Implementation and Expectations

Following the implementation of IN 290/2024, new petitions or those already in the analysis queue may be subject to requests for optimized analysis if the petitioning company expresses interest.

While petitions undergoing optimized analysis will not receive priority status for evaluation at ANVISA, it is anticipated that technical evaluations will be conducted more efficiently. However, approval by ANVISA via optimized analysis is not guaranteed; ANVISA will assess the submission and determine the appropriate analysis procedure.

Regulatory Impact

• Top Priority: No
• Type Certificate: Yes
• Spectrum Bands: No
• Import Changes HS Codes: No
• Standard Changes: Yes
• Product Changes: No
• Label Changes: No

Link to full document - https://drive.google.com/file/d/1k98B32PIH3lH3bADgfpJgqsGTwzjNO1X/view