The Collegiate Board Resolution – RDC 751/2022 was published on the 21^st of September 2022, which provides for risk classification, Notification and Registro processes, and the requirements for medical devices’ labeling and instructions for use.

The new RDC consolidates the risk classification and regularization regimes for all risk classes, unifying 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), which will be revoked. The new resolution also includes the requirements for BGMP’s proof of compliance, currently described in RDC 15/2014 – which will also be revoked.

The procedures for risk classification and regularization of in vitro diagnostic devices (IVDs) are not covered by this resolution and will still follow the guidelines established in RDC 36/2015.

We highlight the main changes of the new resolution:

• Inclusion of new risk classification rules: specific classification rules will be adopted for new technologies, such as Software as Medical Device (SaMD) and nanomaterials. The new classification rules are closely aligned with the EU MDR rules.
• Consolidation of the rules for Notification, Registro, alterations and renewals;
• Adoption of new definitions and concepts, such as updating the definition of a medical device, including the definition of a registration holder, among others;
• Incorporation of the regulation for Medical Devices’ Documentary Repository (mandatory upload of Instructions for Use on ANVISA’s portal), already in force according to RDC 431/2020;
• Incorporation of rules for Instructions for Use in electronic format and their requirements;
• Adoption of the Table of Contents structure (IMDRF’s Table of Contents) for Technical Dossiers, enabling the use of dossiers prepared for multiple jurisdictions (regulatory convergence);
• Possibility of stock depletion of the products, including their packaging, labels and instructions for use in case of alteration of medical devices;
• Formalization of the procedural reassessment process, in which approved Notifications and Registro can be audited by ANVISA’s technical team;
• Text modernization and terminology update.

RDC 751/2022 comes into force on March 1^st, 2023.

In case a medical device registered through the Notification route falls into a higher Risk Class according to the new rules, and needs to be reclassified as a Registro, the new resolution establishes a timeframe of one year from the beginning of its validity for a reclassification petition to be filed.

With the new text, RDC 751/2022 consolidates a series of previous regulations issued by ANVISA, strengthening itself as the main rule regarding the regularization of medical devices in Brazil. The revision of terms and concepts and the modernization of the wording are also factors that lead to communication gain with the regulated sector. Finally, the new Resolution becomes a more internationally aligned normative, either with Mercosur, through the internalization of Mercosur Resolution GMC nº 25/2021, which updated the documentary requirements and classification rules for medical devices applicable to the region, or with European regulation, through the establishment of rules for risk classification similar to the EU MDR.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team