The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. The UDI comprises a device identifier (UDI-DI).
Resolution 1405/2022 states that the owner of the Registration or its representative must inform the UDI-DI of the products already registered in Colombia.
Timelines to inform the UDI-DI: from August 8, 2022 to February 8, 2024 INVIMA socializes the Resolution and the implementation of the UDI-DI
From February 8, 2024 to February 8, 2025: INVIMA must be informed of UDI-DI for registered DMs and IVDs Class III.
From February 8, 2024 to August 8, 2025 INVIMA must be informed of UDI-DI for registered MDs Class IIb and IVDs Class II
From February 8, 2024 to February 8, 2026,INVIMA must be informed of UDI-DI for registered DMs Class Class IIa and I and IVDs class I
We will contact our clients and let you know how we can start this process. Please expect further private communications to comply with this process.
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