Brazil ANIVSA Publishes Additional Clarifications to New Medical Device Regulation RDC 751/2022

By Harrison Emery and Priscila Sanada

Brazilian medical device market regulator ANVISA has issued clarifications regarding submission deadlines under new RDC 751/2022 medical device registration requirements.

On April 18, 2023, ANVISA published additional clarifications in a Technical Note related to RDC 751/2022 (link in Portuguese). This note explained a few provisions related to RDC 751/2022, and also reminded industry that ANVISA didn’t expect many changes in device classification under the new regulations.

ANVISA submission deadlines for up-classified higher-risk medical devices

While RDC 751/2022, had indicated the deadline for submissions for devices which were up-classified to Class III or Class IV as February 29, 2024, the new technical note emphasized this timeframe.

• Manufacturers of Class I or Class II  medical devices (with an existing Cadastro) up-classified to Class III or IV are required to apply for the Registro by February 28, 2024. As a reminder, manufacturers based in Brazil or foreign companies’ Brazil Registration Holders (BRH) must also apply for Brazilian Good Manufacturing Practice (B-GMP) certification.
• Manufacturers of Class III or Class IV medical devices (with an existing Registro) down-classified to Class I or II should submit a rectification petition to ANVISA to modify their device risk classifications.
• Manufacturers of Class III or Class IV medical devices (with an existing Registro) with device classification changes from Class III to IV or from Class IV to III should modify their risk classifications when submitting their next renewal or modification. However, the manufacturer or BRH needs to submit a modification to the B-GMP to have the device classification updated.

RDC 751/2022 became effective in March 2023.

Previous Emergo by UL updates regarding RDC 751/2022 compliance cover classification, technical dossier requirements, grouping and labeling.

Harrison Emery is Research Associate and Priscila Sanada is Consulting Manager