Overview:
ANVISA Brazil announced in early September 2022 important updates to its Collegiate Directorate Resolution (RDC) 185/2001.
The changes strengthen the country’s medical device registration regulations on the effective date of March 1, 2023.
Introduction:
The updates to Resolution of the Collegiate Board of Directors (RDC)No.185/2001 define the documentary requirements and applicable medical device classification rules.
In addition to internalizing the standard, the text consolidates a number of other regulations issued by Anvisa that deal with the medical device regularization process.
Main Changes of the Resolution
- Specific classification rules for new technologies, such as Software as Medical Device and nanomaterials;
- Unification of the rules: of notification, of registration and of changes in a single RDC;
- Incorporation of rules for the Documentary Repository of Medical Devices. Note: this requires uploading the Instructions for Use (IFUs) to an ANVISA portal.
- Incorporation of rules on Instructions for use in non-printed format;
- Adoption of the Table of Contents structure (IMDRF’s Table of Contents) for the Technical Dossiers, allowing the use of dossiers prepared for multiple jurisdictions (regulatory convergence);
- Prevision of situations for depletion of stock of finished products, packaging, labels and instructions for use;
- Formalization of the procedural re-evaluation procedure;
- General modernization of the text and updating of terminology.
Learn more about ANVISA medical device regulations:
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