The Board of Directors Resolution (RDC) 591/2021, issued by the National Health Surveillance Agency (Anvisa), establishes new guidelines for the identification of medical devices in Brazil through the Unique Device Identification (UDI) system. This resolution marks a significant advancement in the traceability of Class IV risk medical devices.
- What is UDI and why is it important? The UDI is a sequence of numeric or alphanumeric characters that allows for the unique identification of medical devices on the market. It plays a crucial role in ensuring patient safety and traceability throughout the supply chain, enabling a quick response in case of adverse events.
Source: gov.com
2. What does RDC 591/2021 establish?
RDC 591/2021 establishes that by July 2024, Class IV risk medical devices must include the UDI on their packaging. Additionally, the resolution defines specific actions to be carried out by companies, such as assigning the UDI, applying the UDI carrier, transmitting information to the UDI database, and including the UDI code in notifications of adverse events, technical complaints, and field actions.
3. What do manufacturers need to do now?
It is crucial that manufacturers are aware of the requirements of RDC 591/2021 and act proactively to ensure compliance with the established deadlines. By July 2024, companies must assign and apply the UDI to their Class IV risk medical devices, thereby ensuring precise identification and adequate traceability.
Source: gov.com
4. Still have questions on how to proceed?
Our experts are available to provide guidance and support throughout the UDI implementation process. Contact us for more information and to ensure compliance with current regulations.
- Read RDC 591/20241here: Link to the Resolution
- The translated version in English is available here: RDC – 591/2021
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