Colombia Device Risk Classification under Decreto 4725 de 2005

1. Key takeaways

Colombia classifies medical devices for human use into four risk classes — I, IIa, IIb and III — and there is no Clase IV. The legal basis for the determination rests on two articles of Decreto 4725 de 2005: Art. 6 provides four grading principles, and Art. 7 provides 18 classification rules organized into four groups covering non-invasive devices, invasive devices, additional rules for active devices and special rules. The classification outcome is not an administrative label; it directly determines two things — which pathway applies (Class I/IIa go through the automatic registration of Art. 17, Class IIb/III through the standard registration of Art. 16) and how much it costs (Class I/IIa pay 321.91 UVB, Class IIb/III pay 364.36 UVB).

The GRZAN regulatory team’s judgment is that Colombia’s classification system shares its origins with the EU MDR, so Chinese manufacturers with existing CE technical documentation can usually carry the classification conclusion over directly. Even so, the conclusion must be recalculated rule by rule under Art. 7 and recorded in writing. The reason is simple: INVIMA correction notices will demand the rule basis, and a classification conclusion you cannot substantiate is equivalent to having no conclusion at all.

2. Legal basis

3. Expert insights

#### The four principles of Art. 6 resolve conflicts rather than assign classes

The four grading principles of Art. 6 are homologous with the EU MDR: systems and sets of instruments are assessed independently, software takes the class of its host device, multipurpose products are graded at the highest risk, and where rules conflict the highest class prevails. What these four have in common is that they do not assign a class directly; they establish the order of adjudication when several rules apply simultaneously. In projects the GRZAN regulatory team has observed that the second principle is the one most often missed: companies split standalone software out of the host device and file it separately, leaving it with neither the support of a host device nor a matching classification entry in SIRIS. The correct approach is to let the software follow the class of the host device and submit it as part of the same application’s technical content.

#### The 18 rules of Art. 7: the grouping dictates the search order

The 18 rules of Art. 7 fall into four groups: non-invasive rules, invasive rules, additional rules for active devices and special rules. This grouping is not there for reading convenience — it implies the order of application: first judge invasiveness and site of action, then layer on the active-device attributes and special mechanisms (such as medicinal substances, animal-origin materials, absorbability). The GRZAN judgment is that companies should compress the recalculation onto a single page: product description, the rule numbers triggered, the conclusion drawn from each rule’s text, the final class, and whether any conflict adjudication under Art. 6 was invoked. That single page can be submitted directly at the correction stage and is far more effective than a long narrative explanation.

#### The classification outcome spills over into UDI, fees and vigilance

Risk classification is not an isolated conclusion. Resolución 1405 de 2022 lists risk classification as one of the regulatory attributes, alongside UDI-DI, GMDN codes, manufacturer information and special storage and packaging conditions, all mandatory fields of the semantic report; the class also determines the fee tier under Resolución 2025067543 (321.91 UVB versus 364.36 UVB). All three must agree — if the class stated in SIRIS, the class in the semantic report and the class on the payment slip diverge, the divergence is treated as inconsistent submission data and triggers a correction. The GRZAN regulatory team recommends a three-way cross-check before payment.

4. Practical recommendations

1. The GRZAN regulatory team completes the recalculation using the four principles of Art. 6 and the 18 rules of Art. 7, producing a one-page classification determination that explicitly lists the rule numbers triggered.
2. For products with existing CE or FDA classification conclusions, perform a comparative recalculation and retain an explanation of any differences; do not simply copy the class number over.
3. For products containing software modules, apply the software-follows-the-host-device principle and submit within the same application as the host device, never as a separate filing.
4. Grade multipurpose products at the highest risk, stating in the classification determination the rule corresponding to each intended use and the justification for taking the highest.
5. Ensure the class the titular enters in SIRIS matches both the semantic report and the fee tier, completing the cross-check before payment.
6. Lock the classification conclusion before starting the technical file, to avoid a mid-course class change forcing rework of the entire table of contents and pathway.
7. For borderline products (medicinal combinations, absorbable materials), search the special rules group first, and where necessary obtain INVIMA’s written position through a formal SIRIS inquiry.

5. Verification checklist

• □ A one-page classification determination has been produced, containing the product description, rule numbers triggered, rule conclusions and final class
• □ The conflict adjudication of the four Art. 6 principles has been checked (systems, software, multipurpose products, rule conflicts)
• □ The Art. 7 rules have been searched in the order of the four groups, with no omission of the special rules group
• □ The class has been confirmed as one of I / IIa / IIb / III, with no Clase IV outcome
• □ The pathway has been confirmed by class: Class I/IIa under Art. 17, Class IIb/III under Art. 16
• □ The class in SIRIS, the class in the semantic report (Resolución 1405 de 2022) and the fee tier are consistent
• □ The fee has been confirmed under Resolución 2025067543: 321.91 UVB or 364.36 UVB

Regulatory information verified as of October 29, 2026

All outward-facing conclusions are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN provides end-to-end INVIMA registration and compliance support for manufacturers entering the Colombian market, covering risk classification, technical documentation, UDI and semantic reporting, SIRIS submissions and post-market obligations. For inquiries about INVIMA registration in Colombia, contact info@grzanglobal.com.