Semantic Reporting Becomes Mandatory in Colombia: The February 2026 Deadline

1. Key takeaways

Article 15 of Resolución 1405 de 2022 set out a tiered transition period: products certified on or after February 8, 2024 must complete semantic reporting before commercialization; Class III devices and IVD Categoría III had 12 months (ending February 8, 2025); Class IIb devices and IVD Categoría II had 18 months (ending August 8, 2025); Class IIa and Class I devices and IVD Categoría I had 24 months (ending February 8, 2026). INVIMA then confirmed through an official communication on March 12, 2026 that the transition period had ended and semantic reporting was fully mandatory.

This means February 8, 2026 is a hard line: before it, an uncompleted semantic report is a compliance gap of the should-have-done variety; after it, semantic reporting is a precondition of commercialization — without it, the product cannot be lawfully sold. GRZAN’s judgment is that the severity of this line is widely underestimated, because it does not present itself as a fine notice; it presents itself as a product being classified as non-compliant circulation during market surveillance.

2. Legal basis

3. Expert insights

1. The tier that expires last is precisely the category where Chinese products concentrate

The design logic of the transition period is that higher risk means a shorter runway. The arrangement is reasonable in itself, yet it creates particular pressure for Chinese manufacturers: Chinese products account for a high share of the Colombian registration database (approximately 61,000 records, per third-party statistics) and concentrate in Class I/IIa and low-risk IVD Categoría I — exactly the last tier. 24 months looks like the most generous allowance, but in practice it means a large batch of products expires at the same moment and is exposed all at once after February 8, 2026. GRZAN advised its clients long ago not to wait for the final tier but to move in step with the high-risk categories.

2. The phrase before commercialization turns semantic reporting into a pre-market condition

The legal weight of this phrase is heavy: the semantic report is not an administrative document that can be gradually completed after the product is on the market; it is a sales eligibility requirement standing alongside the registration certificate. Once the transition period lapses, legacy products left uncompleted fall into the same status — the registration certificate remains valid, but the product does not meet the conditions for lawful sale. GRZAN reminds clients to keep the distinction sharp: holding a valid registration certificate does not equal being able to lawfully sell, and that equality stops holding automatically after February 8, 2026.

3. The consequence chain has no buffer, and the draft decree will close the window once more

The consequences of not completing the semantic report form a chain: non-compliant circulation places the product within the view of market surveillance (the follow-up control under Article 57 of Ley 962 de 2005 and the ex-post verification under Decreto 582 de 2017), which can trigger health safety measures and escalate step by step to suspension of the registration and even cancellation. Every link in that chain is supported by existing rules; no new regulation is needed to make it run. Meanwhile, the draft decree published in January 2026 moves in the direction of pulling UDI forward to the initial application; as of the verification date it has not been signed or published. GRZAN’s judgment is that companies folding the UDI-DI into product master data now will only need to migrate data when that happens, while companies still improvising codes will have to redo the work.

4. Practical recommendations

1. Registration holder (titular): verify the semantic reporting status of all products on sale in SIRIS, list the uncompleted items and rank them by risk.
2. Chinese manufacturers: complete issuing agency selection and UDI-DI assignment before entering data; the order cannot be reversed.
3. Regulatory affairs leads: bind semantic reporting status to sellable status; do not schedule shipments or tenders for uncompleted products.
4. Importers: verify semantic reporting completion at goods receipt; do not accept uncompleted models.
5. Regulatory affairs leads: map IVD products to transition tiers by the Categoría of Decreto 3770 de 2004, not by the device class scheme.
6. Chinese manufacturers: fold the UDI-DI into product master data and label design, preserving the ability to migrate when the draft moves UDI to the initial application.

5. Verification checklist

• □ The semantic reporting status of all products on sale has been verified and the uncompleted list drawn up
• □ It has been confirmed that after February 8, 2026 semantic reporting is a precondition of commercialization
• □ Issuing agency selection and UDI-DI and GMDN term assignment have been completed
• □ Products without completed semantic reports have been suspended from shipment and tender arrangements
• □ IVD products have been correctly mapped to transition tiers by the Categoría of Decreto 3770 de 2004
• □ Filing evidence has been retained and can withstand follow-up controls and ex-post verification

Regulatory information verified as of October 29, 2026

All conclusions published here defer to the current regulatory texts as issued by the competent authority, verified item by item before delivery.

— GRZAN Regulatory Team

GRZAN helps manufacturers close semantic reporting gaps in Colombia: portfolio-wide status checks in SIRIS, UDI-DI and GMDN implementation, issuing agency onboarding, and coordination with technovigilance and recall obligations so that coding, vigilance and registration data stay consistent. To clear your backlog before enforcement reaches it, contact the GRZAN regulatory team at info@grzanglobal.com.