This week, we cover more ANVISA updates from Brazil, including new labeling requirements for certain devices and a clear path for registration transfers, along with new appraisal requirements for high-risk devices in Vietnam.
RDC N° 902:2024 introduces new mandatory labeling requirements (link in Portuguese) for products under sanitary surveillance, including medical devices. The regulation requires companies to include statements like "NEW FORMULA" or "NEW COMPOSITION" on product labels when there is a change in composition. Lay-use medical devices must follow specific guidelines outlined in IN N° 68:2020 to ensure compliance.
Key points of the regulation include:
Pure Global is helping businesses adapt to these changes by revising labels and preparing for regulatory inspections, ensuring full compliance with the new standards.
The new ANVISA resolution, RDC N° 903/2024 (link in Portuguese), published on September 9, 2024, introduces no changes to the existing procedures and deadlines set by RDC N° 102:2016. However, it reinforces and clarifies the processes for transferring product registration ownership and responsibilities related to clinical trials.
Key points of the regulation include:
Main highlights:
How Pure Global can help:
These updates aim to simplify compliance and enhance operational efficiency. Contact our consultants for expert guidance.
For Class C and D medical devices without a certificate from reference countries, registration now requires (link in Vietnamese) a third-party appraisal of the Common Submission Dossier Template (CSDT). The designated third parties are:
The Institute of Medical Equipment and Works has announced a fee of 19,000,000 VND (~$800) for IVD device appraisals, with a timeline of around three months. The fee notice for non-IVD devices is still pending.
Stay informed to avoid delays in the registration process.
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