The Brazilian Health Regulatory Agency (ANVISA) launched a public consultation on the implementation of the Unique Device Identification (UDI) system for medical devices in Brazil. According to the draft resolution, private sector adherence may range from 2- to 6-year adaptation periods.

The Brazilian Health Regulatory Agency (ANVISA) launched Public Consultation n. 1.051/2021, intended to collect public contributions on the incorporation of the Unique Device Identification (UDI) system of medical devices to the Brazilian market. The implementation of the UDI system in Brazil comprises ANVISA’s 2021-2023 Regulatory Agenda, specifically project 11.10 (more information in the 24th edition of the Regulatory Report).

The UDI is an internationally recognized label standard, provided by the International Medical Device Regulators Forum (IMDRF), and designed to promote a harmonized global identification system for medical devices. According to ANVISA, its incorporation to the national level (domestic regulation) is already provided in countries such as Saudi Arabia, South Korea, Taiwan, Turkey, Japan, United States, and the members of the European Union.

The public consultation provided a draft RDC resolution for the implementation the UDI system. The draft resolution establishes general requirements, lists the recognized UDI issuing bodies, and provides the implementation of an UDI database by ANVISA. It also provides an adaptation period (deadline) for company adherence to the proposed regulation, depending on the risk classification of each medical device, specifically:

  • 2-year adaptation period for “risk class IV” medical devices;
  • 3-year adaptation period for “risk class III” medical devices;
  • 4-year adaptation period for “risk class II” medical devices; and
  • 6-year adaptation period for “risk class I” medical devices.

Public contributions can be submitted through this form until September 6. The draft resolution and technical notes can be found at ANVISA’s website. The regulatory process for providing regulation on the incorporation of the UDI system in Brazil is scheduled to be concluded by the end of 2021.