Brazil: UDI requirements for medical devices for manufacturers

ANVISA, the Brazilian medical device market regulator, has released a proposed framework for Unique Device Identification (UDI) standards, which will be open for public comment until August 2021. Referring to ANVISA Public Consultation 1051/2021, the regulator intends to implement UDI regulations over a six-year period in order to improve traceability and supervision of medical devices and equipment sold in Brazil.

ANVISA UDI Key Compliance Schedule for Medical Device Manufacturers

· 2 years for Class IV (highest risk) devices

· 3 years for Class III (high risk) devices

· 4 years for Class II (moderate risk) devices

· 6 years for Class I (low risk) devices

Registrants of reusable medical devices with a direct UDI mark will be granted an additional two years after the above compliance schedule. Customized devices and investigational devices are not subject to the UDI requirements.

ANVISA UDI database requirements

The public consultation also provided detailed information on the UDI database submission requirements for registrants. Other than that, ANVISA intends to develop its own UDI database where manufacturers and registrants can upload the required UDI data. Once the database is established, the registrants are responsible to make sure UDI data of their devices is sent to the database before it is marketed in Brazil.

The UDI data sent to the database must contain Global Device Nomenclature (GMDN) codes, and registration holder must present the UDI numbers on post-market vigilance notifications of their medical devices.

Sources:

Public Consultation 1051/2021

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