What is the system

The Unique Identification System for Medical Devices (UDI)/Unique Device Identification (UDI) is an international standard that intends to consolidate itself as a global and harmonized system of identification of medical products, according to their distribution and use in patients. ​​​​​establishing a guarantee of traceability and a globalized surveillance system. It is a model based on the guidelines of the IMDRF (International Medical Device Regulators Forum) and has already been applied within regulatory agencies in countries such as the US, Japan and South Korea.

The UDI Identification System also involves the creation of a public database by the regulatory agency.

What is UDI

According to the IMDRF Guide on the subject, the UDI is a numeric or alphanumeric sequence, created through a globally accepted device identification and a coding standard, which is formed by two parts: DI and PI, and is affixed to the label and/or on the product itself.

The UDI-DI (Device Identifier) ​​is an identification code specific to a device model (therefore, a fixed code between products of the same model) and gathers information such as the GTIN number.

The UDI-PI (Production Identifier) ​​is a variable code and references manufacturing data, such as manufacturing and expiration date, batch, serial number, etc.

These combined characters allow the unambiguous identification of a certain medical device on the market, thus ensuring patient safety at different levels and facilitating the logistics of the distribution chain.

The UDI System and ANVISA

Public Consultation No. 1,051/2021, which encompasses a proposal for a Resolution of the RDC Collegiate Board of Directors that provides for the positive identification of regularized medical devices at Anvisa, through the Unique Identification of Medical Devices (UDI) system, was open to the public for contributions until the beginning of September (06/09/2021).

The Agency's latest forecast is that in December/2021 the analysis of the Collegiate Board of Anvisa would take place, and consequently the publication of the RDC.

Relevant questions on the topic

What types of medical products will need UDI according to the public consultation?

Anvisa's proposed resolution is directed to medical products and products for in vitro diagnosis, regulated by RDC No. 185/2001, RDC No. 36/2015, and RDC No. 40/2015, with the exception of made-to-measure medical devices and medical devices in clinical investigation.​​​​​​​

What are the implementation deadlines according to the public consultation?

Article 15 of Public Consultation No. 1.051/2021 states that the deadlines for assigning the UDI and applying the UDI supports, after the effective date of the Resolution, will be:

  • 2 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. ​​​​​​​

Furthermore, the Consultation also brings several details regarding these deadlines, it is worth reading if you are a manufacturer, importer and/or distributor of medical products.

And the availability of information in Anvisa's UDI Database?

The submission of data follows the same schedule as the assignment of UDI and supports, but counting starts from the moment Anvisa publishes in a normative instruction that the Agency's UDI database is able to receive the information.​​​​​​​

What are the issuing entities of UDI?

Public Consultation No. 1,051/2021 initially foresees that issuing entities will be:

  • GS1
  • HIBCC (Health Industry Business Communications Council);
  • ICCBBA (International Council for Commonality in Blood Banking Automation).

Collaboration: Regulated Product Strategy Team
Segment of interest: Health Products

Bibliographical References: www.gov.br/anvisa/pt-br