The most important regulation for Medical Devices in Brazil is RDC 751/2022, which provides for the risk classification, notification and registration regimes, labeling requirements, and instructions for use of medical devices. This new regulation published in 2022 has now recently entered into force on March 1, 2023.
This resolution promotes the internalization of Mercosur Resolution GMC 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.
This resolution seeks to bring together all issues related to the regulation of medical devices in a single RDC.
- Adoption of specific classification rules for new technologies such as Software as Medical Device (SaMD) and nanomaterials.
- Inclusion of Medical Device Documentary Repository standards and instructions for use in non-printed format.
- Adoption of the Table of Contents structure for Technical Dossiers, enabling the use of dossiers prepared for multiple jurisdictions.
- Provision 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 terminologies.
GRP Brazil Medical Device Expertise
Count on the specialized consultancy of GRP Brazil to Register your product in Brazil, we have an expert team in Regulatory matters in Brazil. GRP Brazil is also a licensed Brazilian registration Holder, supporting your complete market access into Brazil.
Read more about the full DRC by clicking on the following link: in Portuguese only.
GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.