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.
Compatibility with International Systems
Resolution 1405 accepts UDIs generated through the following Code Issuing Entities:
- GS1HIBCC
- 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