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.
Learn more about ANVISA Brazil Medical Device Labeling Requirements.
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.
Learn more about ANVISA Brazil Medical Device Registration.
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.
Learn more about MOH Vietnam Medical Device Registration.
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The IVDR transition includes structured processes IVD manufacturers must follow to engage with Notified Bodies. Many IVD manufacturers are interacting with Notified Bodies for the first time and must understand what is required to ensure a successful partnership. In this article, Dr. Oliver Eikenberg clarifies what manufacturers must prepare and when to engage a Notified Body for IVDR CE Marking.
Class D IVD manufacturers face fast-approaching IVDR transition deadlines, though some are more familiar with the regulatory process. In this article, Dr. Oliver Eikenberg discusses the difference between "new" and "old" Class Ds, and regulatory logistics they need to consider during the transition process.
Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.
