In September 2022, the Brazilian Health Surveillance Agency, ANVISA, issue a new regulation (RDC 751/2022) that aims to define the risk classification, labeling requirements and instructions for use, and the procedures for notification, registration, amendment, revalidation and cancellation of notification or registration of medical devices.
The new RDC incorporates the Mercosur Resolution GMC No. 25/2021 and consolidates a series of other regulations issued by Anvisa that deal with the regularization process for medical devices.
It will become effective on March 1, 2023, and medical device registration petitions will be accepted with the technical report structure provided for in the RDC No. 185/2001, filed until February 28, 2023.
Check out the main highlights of the new RDC751/2022:
- Adoption of specific classification rules for new technologies, such as Software as Medical Device (SaMD) and nanomaterials;
- Consolidation of the notification, registration, and amendment rules in a single RDC;
- Incorporating Medical Device Documentary Repository Regulations;
- Incorporation of rules about Instructions for Use in a non-printed format;
- Adoption of theIMDRF Table of Contents structure for Technical Dossiers, enabling the use of dossiers prepared for multiple jurisdictions (regulatory convergence);
- Prediction of situations for stock-outs of finished products, packaging, labels and instructions for use;
- Formalization of the procedural reevaluation procedure; and
- General modernization of the text and updating of terminology.
Download the Portuguese or English version of RDC 751/22 below.
