Anvisa has recently announced an update to safety and performance requirements for medical devices, including in vitro diagnostic devices (IVDs), through RDC 848/2024. This measure, approved in the last meeting of the Collegiate Directorate (Dicol) on Wednesday (06/03), brings significant advancements since the replacement of the previous standard, RDC 56/2001.
What’s Changing? With technological advancements over the last 23 years, the new resolution aims to adapt regulations to innovations in the field of medical devices. The updated requirements seek to enhance technical assessment by Anvisa, addressing the challenges posed by new technologies and the diversity of devices.
One of the benefits of this update is enhanced guidance for manufacturers: they will have clear guidelines on the studies and evidence required for product registration, increasing the robustness of the submitted documentation.
Regulatory Harmonization: This move by Anvisa also aligns with efforts towards regulatory harmonization in Mercosur, adopting the Mercosur Technical Regulation based on the guidelines of the International Medical Device Regulators Forum (IMDRF).
In addition to updating essential safety and performance requirements, the new RDC also incorporates the Mercosur Technical Regulation into the national legal framework, repealing Resolution GMC 72/98.
For manufacturers and healthcare professionals, this is a good time to familiarize themselves with the new guidelines and ensure their products and practices are fully compliant.
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- Read RDC 848/2024 here: Link to the Resolution
- The translated version in English is available here: RDC – 848/2024
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