ANVISA plans major medical device registration updates.
Brazil’s medical device market regulator, ANVISA, announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of March 1, 2023.
The updates to RDC No. 185/2001 further define the rules for classifying the risk of medical devices, the requirements for labeling and instructions for use and the procedures for notification or registration of medical devices.
The resolution’s major changes include:
- Adoption of specific classification rules for new technologies, including software as a medical device (SaMD) and nanomaterials.
- The updated classification rules generally align with EU MDR classifications.
- Consolidation of notification, registration and change rules in a single RDC.
- Incorporation of rules for the Documentary Repository of Medical Devices. Note: this requires uploading the Instructions for Use (IFUs) to a ANVISA portal.
- Incorporation of rules for IFU format.
- Adoption of the Table of Contents structure (IMDRF’s Table of Contents) for Technical Dossiers, enabling the use of dossiers prepared for multiple jurisdictions.
- Forecasting situations for depletion of finished products, packaging, labels and IFUs.
Formalization of the procedural reassessment process.
- General modernization of the text and updating of terminology.