In an effort to align with global best practices and strengthen the
traceability and safety of Medical Devices (MD) and In Vitro Diagnostic (IVD) Devices,
Colombia has introduced new requirements for the registration of Unique Device
Identifiers – Device Identifier (UDI-DI). The Ministry of Health and Social
Protection published Resolution 1405 of 2022, which structures and regulates
the implementation of the semantic standard and coding for medical devices for
human use and invitro diagnostic reagents. If you are a Marketing Authorization
Holder (MAH) for Medical Devices or IVD Devices already registered in Colombia,
these updates are particularly pertinent. Here is what you need to know.
Who must report the UDI-DI to the
National Institute for Food and Drug Surveillance (INVIMA)?
Holders of current health registrations for Medical Devices
for human use and IVD Devices.
What is UDI-DI?
The Unique Device Identifier – Device Identifier (UDI-DI)
is a globally recognized identification system used to uniquely identify Medical
Devices and IVD devices throughout their distribution and use. It plays a key
role in product traceability, post-market surveillance and patient safety.
Key Dates and
Deadlines
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Phase
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Due date
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Classification
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***
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Before commercialization
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UDI Registration for MD and IVD, all risks. Permits
obtained from February 2nd, 2024
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Phase 1
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February 8th, 2025
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UDI registration for MD and IVD, Class III
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Phase 2
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August 8th, 2025
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UDI registration for MD Class IIb and IVD Class II
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Phase 3
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February 8th, 2026
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UDI registration for MD Class IIa and Class I and IVD
Class I
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Compatibility with International Systems
Resolution 1405 accepts UDIs generated through the
following Code Issuing Entities:
- GS1
- HIBCC
- ICCBBA
- IFA
- Ali Health (China)
- ZIIOT (China)
This is great news for manufacturers already complying with
UDI requirements in the United States, European Union, or other regions.
Final Thoughts
Colombian
UDI-DI reporting requirements offer several benefits, including improved
patient safety through better device traceability, alignment with international
standards for easier global market access, and enhanced regulatory oversight.
If you are placing your Medical Devices or IVDs on the
Colombian market, make sure that your devices are compliant. In case you have
any questions, please do not hesitate to reach out to the Qserve Global
Registrations Department via globalreg@qservegroup.com