UDI for Brazil – ANVISA
Published on December 29th, 2021, and effective as of January 10, 2022, ANVISA informed that it will require the UDI (Unique Device Identifier) in the labeling of registered products and marketed in Brazil.
The UDI is composed of the UDI-DI (DI = Device Identifier) and the UDI-PI (PI = Production Identifier).
UDI-DI: Unique numeric or alphanumeric code, specific to a device model, which is also used as an “access key” to information stored in a UDI database.
UDI-PI: Numerical or alphanumeric code that identifies the device’s production unit. The different UDI-PI types include one or more of the following information: serial number, batch number, version (for Software as a Medical Device – SaMD), date of manufacture, and expiration date.
The measure is part of a worldwide trend to improve the traceability and safety of our medical devices.
The implementation deadlines are already defined, based on the risk class of each product*. Please see below:
- 2.5 years for risk class IV medical devices.
- 3 years for risk class III medical devices.
- 4 years for risk class II medical devices.
- 6 years for risk class I medical devices.
*Some products are treated exceptionally and may have a different deadline/condition for implementation.
The UDI must be generated by an issuing agency.
Passarini can support you in understanding and implementing the UDI in your labeling.
For more information and explanations about it, send us an e-mail: [email protected]