Anvisa updates rules for RDC nº 185/2001 – regulation of medical devices in Brazil
Anvisa released on its website on Wednesday (14/09) a news informing about the update of the rules for regularization of medical devices in Brazil. According to Anvisa, the Collegiate Board approved the proposal that revises RDC 185/2001, which is the current legislation.
The new RDC has not yet been published, but Anvisa has already advanced some changes that will appear in the text of the new RDC, as follows:
“The new text promotes the internalization of Mercosur GMC Resolution No. 25/2021, which, at the initiative of Brazil, updated the documentary requirements and classification rules for medical devices applicable to the region. In addition to the internalization of the standard, the text consolidates a series of other regulations issued by Anvisa that deal with the process of regularization of medical devices.
Highlights of the new text are:
- Adoption of specific classification rules for new technologies, such as Software as Medical Device and nanomaterials;
- Consolidation of rules for notification, registration and changes in a single RDC;
- Incorporation of rules for the Documentary Repository of Medical Devices;
- Incorporation of rules on Instructions for Use in non-printed 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 (regulatory convergence);
- Prediction of situations for depletion of finished products, packaging, labels and instructions for use;
- Formalization of the procedural reassessment procedure; and
- General modernization of the text and updating of terminology.
The new RDC will take effect on March 1, 2023, in order to allow the productive sector to make the necessary adjustments in its future petitions to Anvisa”.
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For more information and explanations about it, send us an e-mail: contato@passarini.com.br.
Passarini Group
Published: 16/09/2022 – Source: Anvisa
