The Brazilian Health Regulatory Agency (ANVISA) incorporated the Unique Device Identification (UDI) international label standard system to the Brazilian market of medical devices. A timeline for corporate adaptation was established.

RDC Resolution n.º 591/2021 from the Brazilian Health Regulatory Agency (ANVISA) established the Unique Device Identification (UDI) system of medical devices for the Brazilian market. The UDI is an internationally recognized label standard designed to harmonize global identification systems for medical devices, whose incorporation into the Brazilian regulation was the subject of Public Consultation n.º 1.051/2021 and is part of ANVISA’s 2021-2023 Regulatory Agenda (reported in the 25th edition of the Regulatory Report).

The new resolution concerns the medical devices regulated by RDC Resolutions n.º 185/2001, n.º 36/2015, and n.º 40/2015 (article 1), contemplating all medical devices regulated by ANVISA, except those described in article 2. As stated in article 4, suppliers and holders of product registrations for medical devices must adhere to the general provisions from articles 5 and 6 and the identification requirements from articles 7 to 10.

The recognized UDI issuing entities are listed in article 11, while the framework for a national UDI database, which will be developed by ANVISA, is provided in articles 12 to 14. Article 15 establishes transition periods for companies to adhere to the new system, once ANVISA enacts a normative instruction confirming that the UDI database is operational (capable of receiving the information described in article 15). Those transition periods are defined by the risk classification of medical devices, specifically:

  • 2.5-year (two-and-a-half years) 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.