Since 2024, INVIMA has required full compliance with the semantic standard for these products — yet over 85% of registrations have not reported their UDI-DI codes and other required attributes. Time is running out, and penalties are coming. Here we explain exactly what INVIMA requires, how to do it right, and how to avoid costly mistakes.
1. What is a Class IIb medical device?
Under INVIMA’s classification system, Class IIb devices are medium- to high-risk products such as catheters, infusion pumps, monitoring systems, ventilators, and non-permanent implants. Their risk level requires stricter regulatory control and more comprehensive technical documentation.
2. What does INVIMA require for Class IIb devices in 2025?
As of July 1, 2025, INVIMA has reiterated the following key requirements to maintain authorization for marketing Class IIb medical devices in Colombia:
- Properly reported semantic standard
- This is both a technical and legal requirement.
- Submitted through INVIMA’s medical device coding platform.
- Must use standardized terminology and structures defined by the Global Medical Device Nomenclature (GMDN).
- This is both a technical and legal requirement.
- Updated technical and labeling data
- Manuals, technical sheets, and labels must align with the standard.
- Avoid ambiguous or generic terms.
- Manuals, technical sheets, and labels must align with the standard.
- Documentary support and traceability
- Your registration must be backed by technical documentation, validations, certifications, clinical trials, or biocompatibility tests (as applicable).
- Your registration must be backed by technical documentation, validations, certifications, clinical trials, or biocompatibility tests (as applicable).
- Manufacturer and origin validation
- All manufacturer documents must be legalized and up to date.
- All manufacturer documents must be legalized and up to date.
Product origin must match what was reported to INVIMA.
3. What happens if you do not comply?
- Loss of the sanitary registration
- Financial penalties
- Temporary ban on commercialization
- Reputational damage with clients, distributors, and tenders
4. How can you check if your device has reported the standard?
You can verify your registration status on INVIMA’s official portal:
Real Case
A company with four Class IIb registrations had not reported the semantic standard. INVIMA issued formal requirements. With the support of Nieto Lawyers, all documentation was updated in just 15 days, avoiding penalties. The company was able to participate again in public tenders in 2025.
Why work with both legal and technical advisors?
- INVIMA’s technical and legal language can be complex.
- Reporting the standard is not just “uploading a file.”
- Every mistake costs time — and time is money.
- The right guidance prevents rework and penalties.
Not sure if your device is compliant?
At Nieto Lawyers, we offer a free review of your regulatory compliance status.
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