Colombia INVIMA 2026 Guidance Clarifies UDI-DI Requirements for Class IIa Medical Devices

Colombia’s INVIMA 2026 UDI-DI guidance for Class IIa medical devices clarifies the compliance requirements for products registered before February 2024. Manufacturers and distributors must incorporate the Unique Device Identification – Device Identifier (UDI-DI), as established in Article 15 of Resolution 1405 of 2022, to ensure regulatory compliance and uninterrupted commercialization. This update follows our previous Weekly Regulatory update posted on 10th September 2024, which announced Colombia’s plan to implement the UDI system for medical devices and IVDs starting in 2024. Early preparation can prevent delays, extra fees, or noncompliance penalties.

Key Updates in INVIMA UDI-DI Requirements (2026)

• Class IIa medical devices registered before February 2024 must include UDI-DI coding.

• Deadline is February 9, 2026, adjusted from February 8 because it falls on a non-working day.

• Early submission is recommended six weeks before the deadline to allow review and approval.

Impact of Non-Compliance

• Devices without UDI-DI coding by the deadline cannot be commercialized in Colombia.

• INVIMA will consider registrations noncompliant, risking market interruption.

How to Comply with UDI-DI Requirements

• Review your Class IIa device portfolio to ensure all registrations meet current standards.

• Obtain official instructions and submit UDI-DI coding early.

• Consult regulatory experts if needed to guide the submission process efficiently.

Recommended Timeline

• Begin the incorporation process at least six weeks prior to February 9, 2026.

• Allow time for review, approval, and submission to INVIMA to avoid delays.

Internal Links

• Learn more about Colombia INVIMA Medical Device Registration

• Check Medical Device Classification and Grouping

External Links

• INVIMA Official Resolution 1405 of 2022 PDF

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