The Brazilian Health Regulatory Agency (ANVISA) issued the new medical device regulation RDC No. 751/2022 on Sept. 21, 2022.


The new RDC consolidates medical device risk classification, the Notification and Registro regimes (including registration modification requirements), and the requirements for medical devices’ labeling and instructions for use for all risk classes.

This update revokes RDC 185/2001 (classification rules and procedures for Registro – class III and IV medical devices) and RDC 40/2015 (procedures for Notification and technical dossier – risk class I and II medical devices).

The new resolution also includes the requirements for Brazilian Good Manufacturing Practices’ (B-GMP) proof of compliance. Brazil’s New RDC 751/2022 Incorporates European MDR Risk Classification Rules Brazilian regulators align medical device classification rules to those of EU MDR.

Overview of New Brazilian Regulation

  • ANVISA guides manufacturers in the FAQ to include respective files in each chapter. And separate files for each item may be necessary. Further, to harmonize compilation and review, ANVISA will soon publish guidance.
  • Chapter 3 requires the List of Essential Security and Performance Requirements (Lista dos Requisitos Essenciais de Segurança e Desempenho);device must be compliant to RDC 546/2021.
  • Organization of the submission is presented in a Table. This is aligned with the International Medical Device Regulators Forum (IMDRF) guidance.
  • Rule 2 applies to blood bags.
  • Rule 6 now includes the central nervous system; and breast implants as well as joint prostheses are added to.
  • Rule 8 as Class IV devices.
  • Rule 16 of RDC 751/2022 states that artificial tears and ophthalmic lubricants, when classified as medical devices, would be Class III.
  • Rule 16 of RDC 751/2022 states that artificial tears and ophthalmic lubricants, when classified as medical devices, would be Class III.
  • The submission must now be organized according to IMDRF/RPS WG/N9 (Edition 3) FINAL:2019 – Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC).

Learn more about regulations:

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