Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers

Brazilian medical device market regulator ANVISA has rolled out its proposed framework for Unique Device Identification (UDI) requirements, and is seeking public comment on the new rules through August 2021.

According to ANVISA Public Consultation 1051/2021 (link in Portuguese), the regulator plans a six-year rollout of UDI requirements in order to boost traceability and monitoring of medical devices and equipment commercialized in Brazil.

Key ANVISA UDI compliance timelines for medical device manufacturers

UDI compliance lead times for manufacturers will depend on the risk classification of their devices:

• Two years for Class IV (highest risk) devices
• Three years for Class III (high risk) devices
• Four years for Class II (moderate risk) devices
• Six years for Class I (low risk) devices

Emergo by UL consultants anticipate that ANVISA will review stakeholder feedback on the public consultation through November 2021, then issue a final regulation on UDI in December 2021. Based on these projections, Class IV device registrants would face a December 2023 deadline for UDI compliance.

Registration holders of reusable medical devices with direct UDI marking will be granted two additional  years following the deadlines listed above for compliance; custom-made devices as well as investigational devices are exempt from UDI requirements, according to the consultation.

ANVISA UDI database requirements

The ANVISA public consultation also provides details regarding UDI database submission requirements for Brazil medical device market registrants.

ANVISA plans to establish its own UDI database into which manufacturers or their Brazil Registration Holders (BRH) will upload required UDI data. Once the database has gone live, BRHs will be responsible for ensuring that device UDI data is submitted to the database prior to commercialization in Brazil. Furthermore, submissions to the UDI database must also include Global Device Nomenclature (GMDN) codes, and device registration holders will be required to include UDI numbers on post-market vigilance notifications involving their products.

Emergo by UL will provide further details on UDI database rules once ANVISA publishes a full Normative Instruction.

Additional Brazilian medical device regulatory resources from Emergo by UL:

• Brazil ANVISA medical device registration and approval consulting
• Brazil Registration Holder (BRH) in-country representation