Borderline Products and CCAA: The reasons why INVIMA will initiate an ex officio review of your portfolio

Did you know that INVIMA can cancel your sanitary registration overnight, even if it has a 10-year validity? The mechanism is known as "Ex Officio Review", and the Colombian health authority is applying it massively to importers and manufacturers who neglect their logistical, clinical, and quality management.

Here we expose the main causes why companies are losing their registrations (and their millionaire investments) in 2026.

1. Neglect of the CCAA (Storage Capacity Certificate)

The CCAA is the backbone of quality in Colombia. The Specialized Chamber has ordered immediate cancellations to companies that:

• Let their certificate expire without requesting renewal on time.
• Move their warehouse without notifying and requesting a new visit.
• Have subcontracted a logistics operator but in practice do not use their certified facilities.

Key Note: Even if you only import Medical Software (an intangible product), the rule obliges you to certify your documentary processes through a CCAA.

2. Misclassified Borderline Products

Do not assume that a product is a medical device just because your international supplier labeled it so. If the technology you import bases its main action on pharmacological, immunological, or metabolic principles, it will be reclassified. Critical examples that are being removed from the Medical Devices category:

• Solutions with Chlorhexidine or Povidone-Iodine.
• Pre-filled syringes with Heparin for catheter flushing.
• Intimate lubricants with local anesthetic.

3. Irregular Groupings (Prohibited Kits)

Putting together commercial combos can be a good sales strategy but a regulatory disaster. Grouping a medical device together with a cosmetic or a medicine in the same primary packaging (kit) is a strict cause for an ex officio review by INVIMA. Regulatory categories must not be mixed under a single coverage.

4. Failures in Technovigilance and Technical Direction

Your Technical Director cannot be a paper figure. They are responsible for escalating serious adverse events within a maximum of 72 hours through the FOREIA platform (or using the ASS-RSA-FM171 formats if you are in the clinical investigation phase). Furthermore, INVIMA actively audits whether the Technical Director has too many simultaneous commitments in other companies, which would diminish their capacity to ensure your quality.

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Sources and Legal Disclaimer: This document has been drafted by Vexpro Consultores for informational purposes. Based on Acts 4 of 2025, 18 of 2021, 16 of 2023, and 6 of 2024 of the SEDMRI (INVIMA). It does not replace the official concept of the health authority.