At the end of June 2021, the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) presented new details on the next UDI system on Medical Devices in a motion (Consulta Publica 1051/2021).
In this document, ANVISA suggests different deadlines to allow Medical Devices Manufacturers to conform to UDI requirements, fundamental to boost Medical Devices traceability and monitoring in the Brazil market.
What about the deadlines for the Manufacturers?
Deadlines depend on the issuing date of the final UDI regulation, scheduled for December 2021, and the devices risk class. The draft includes:
- 2 years for Class IV devices (highest risk).
- 3 years for Class III devices (high risk).
- 4 years for Class II devices (moderate risk).
- 6 years for Class I devices (low risk).
Involved parties have time to send their feedback on the proposal until November 2021. After that, ANVISA will examine feedbacks received before issuing UDI final regulation. In the event that this timing is confirmed, for example, the deadline Class IV Medical Devices Manufacturers would be December 2023.
ANVISA foresees as well to establish its own UDI database in which Manufacturers, or their Brazil Registration Holders (BRH), will upload UDI data required. BRHs will be responsible for guaranteeing that device’s UDI data will be sent to the database before their marketing in Brazil.
Furthermore, the submissions to UDI database must include the Global Device Nomenclature (GMDN) codes.
For further information on UDI database, it is though necessary to wait the final regulation issuing by ANVISA.
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Entrust yourself to Thema experts. Check out the Country Sheet Medical Device Registration in Brazil to get the main information on registration procedure and contact us for a consultation!
We will help you during the entire registration process to market your device in full compliance with Brazilian regulation.