Anvisa Approves New Regulations for Medical Devices in Brazil

On March 6th, the Brazilian Health Regulatory Agency (Anvisa) approved a new resolution addressing the essential safety and performance requirements for medical devices and in vitro diagnostic devices (IVD). This significant development comes as a response to the evolving landscape of medical technologies and the need for updated regulatory frameworks.

The approved resolution revises the existing RDC 546/2021, which had replaced the previous resolution RDC 56/2001. Over the course of 23 years since the last revision, advancements in technology have presented challenges to Anvisa in ensuring the thorough technical evaluation of these products.

The updated essential safety and performance requirements empower the regulatory authority to assess these aspects in light of new technologies and the increasing diversity of medical devices. This move is crucial for maintaining the highest standards of safety and efficacy in the rapidly evolving field of healthcare technology.

One of the key benefits of these revisions is the facilitation of manufacturers’ efforts to provide comprehensive evidence and studies supporting product registration requests. The updated requirements offer clarity, streamlining the documentation submitted to Anvisa and enhancing the robustness of the evaluation process. This, in turn, is expected to expedite the agency’s review, as the submitted evidence will be structured and clearly identified with internationally applicable essential requirements.

Since 2020, Anvisa has been actively collaborating with other Mercosur member states to comprehensively review requirements and definitions applied to the Mercosur Resolution. The primary reference for this collaborative effort has been the document issued by the International Medical Device Regulators Forum (IMDRF), specifically the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N47FINAL: 2018).

The new resolution will incorporate into the national legal framework the Mercosur Technical Regulation on the Essential Safety and Performance Requirements for Medical Devices and In Vitro Diagnostic Devices. Notably, this will replace the previous GMC Resolution 72/98.