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The deadline for UDI to comply with ANVISA is approaching

With the publication of RDC (Collegiate Board Resolution) No. 591/2021, ANVISA established the requirement to identify medical devices in its regulated products using the UDI (Unique Device Identification) system.

The UDI is the set of codes formed by the DI (Device Identifier) + PI (Production Identifier).

The implementation of UDI in Brazil is based on a global strategy that prioritizes the promotion of patient safety through improved traceability, efficiency and management of devices in the supply chain.

The first regulatory agency to adopt UDI was the FDA (Food and Drug Administration), starting in September 2013, and since December 2022 it has required all classes of devices to have this identification. In Europe, it was already mentioned in 2017 in MDR 2017/745 and since 2022 the database has been ready for registration.

ANVISA’s UDI registration database has not yet been released, but this will not be a reason not to implement it. After the deadline set in the RDC, manufacturers will not be able to market devices without identification.

The risks of a lack of UDI can lead to sanitary infractions, resulting in the suspension of the marketing, import and/or use of the medical device. The resolution came into force on January 10, 2022 and the deadlines for adapting the UDI in products registered and marketed by ANVISA are:

  • 07/2024 for risk class IV medical devices

  • 01/2025 for risk class III medical devices

  • 01/2026 for risk class II medical devices

  • 01/2028 for risk class I medical devices

The UDI is the sequence of characters that identifies a device on the country’s market and must be presented in a machine-readable (MR) and human-readable (HR) format.

This identification must be located on the device or on its own packaging and each higher level of packaging must contain its own UDI. It is generated by an issuing agency and is presented as follows:

  • UDI-DI: device identification numbers, consisting of the manufacturer and model identification numbers. They are prefixed with “01”.
  • UDI-PI: the device’s production identification numbers, such as the expiration and manufacturing date, batch number and serial number. They are prefixed with the numbers (17”, “11”, “10” and “21”, respectively.
identifica unicamente o dispositivo

The process of implementing UDI may seem complex, but Passarini Group is ready to help you. We are available to assist you, just contact us by e-mail: [email protected].

Passarini Group

Published on: 04/29/2024

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