Colombia Class IIb/III Standard Registration Review Insights

1. Key takeaways

Class IIb/III devices in Colombia fall under the Registro Sanitario (standard registration) of Article 16 of Decreto 4725 de 2005, with a statutory review period of 90 business days, and that period excludes deficiency round trips — the deficiency response period itself is 90 days. The statutory period describes only the segment during which the reviewing authority is working; the time an applicant takes to answer deficiencies does not count within it. Scheduling the two segments separately is what constitutes a complete filing timeline model.

GRZAN must state one boundary clearly: the public texts of Decreto 4725 de 2005 and its amending decrees contain no provision-level, verifiable rules on the internal organization of technical review, including the composition, deliberation and voting rules of what the industry calls the Sala Especializada; such practice is internal working procedure of INVIMA. The review focus points discussed in this article are therefore anchored in the technical document list expressly required by law (Art. 18) and the classification rules (Art. 7), and no inference is made about the operation of internal bodies. This is the boundary within which GRZAN can be accountable to clients.

2. Legal basis

3. Expert insights

#### Standard registration reviews the chain of evidence, not single documents

The technical document list under Art. 18, on the standard registration pathway, is not a matter of submitting everything and being done; it is a matter of documents corroborating one another. The classification conclusion must trace back to the specific rules of Art. 7, the risk class must match the strength of the technical arguments that follow, and every claim must have a verifiable primary source. Across review responses, GRZAN consistently observes that the large majority of deficiencies arise not from a missing document but from an unexplainable gap between two documents — an intended use in the instructions for use that conflicts with the premises of the classification determination is the most common form.

#### 90 business days and 90 days are two separate clocks

The statutory review period of 90 business days and the deficiency response period of 90 days are two clocks running independently: the authority’s clock stops when a requerimiento issues and the applicant’s clock starts; when the response is submitted, the authority’s clock resumes. In practice there may be more than one round trip. GRZAN does not schedule on a simplified ninety-plus-ninety calculation but models by round — each deficiency round requires reserving fresh authority review time. Treating a deficiency as a one-time surprise is the direct cause of schedule blowouts.

#### The classification conclusion is the foundation of the entire filing

Art. 6 establishes four classification logics: components of a system or kit are assessed independently, software follows its host device, multi-purpose devices take the highest risk, and conflicting rules resolve to the highest class. Art. 7 provides 18 rules in four groups: non-invasive, invasive, active-device additions, and special rules. For Class IIb/III products, once the classification conclusion enters the filing materials it becomes the premise of every subsequent technical argument. GRZAN’s position: the quality of the classification determination determines how many round trips occur within the 90 business days; effort saved at this step is repaid at a multiple during the deficiency stage.

#### Language and standing are formal elements that can halt the file outright

Foreign manufacturers cannot file directly; they must designate a Colombian legal representative (apoderado / representante legal) with the power of attorney executed per Art. 29, and all submitted documents must be in Spanish, with technical or scientific information acceptable in English accompanied by an official Spanish translation. These are formal elements, but on the standard registration pathway formal defects weigh more heavily than on automatic registration — review proceeds item by item, so formal problems create standstill early. GRZAN recommends running formal verification as an independent pre-submission step, not blended into content preparation.

4. Practical recommendations

1. Before submission, the GRZAN regulatory team completes a cross-consistency check across the classification determination, technical arguments, instructions for use and labeling, producing a filing consistency checklist.
2. The titular’s local apoderado completes formal verification before SIRIS submission, focused on validity of the power of attorney (Art. 29), completeness of Spanish translations, and consistency of signing entities across documents.
3. The project manager models the schedule by round: reserve authority review time for each deficiency round and never commit externally to the single figure of 90 business days.
4. The technical documentation lead ensures every claim traces to a primary source and organizes the index in Art. 18 order so review can be checked item by item.
5. Finance budgets the Class IIb/III registration fee of 364.36 UVB on the 2026 fee schedule and reserves the technical-nature modification fee of COP 1,060,243.
6. Compliance confirms that semantic reporting and UDI-DI under Resolución 1405 de 2022 have been completed within the Class IIb transition period (18 months, ending August 8, 2025); since March 12, 2026, semantic reporting is fully mandatory.

5. Verification checklist

• □ The classification determination cites the specific rule numbers of Art. 7 and covers all four classification logics of Art. 6
• □ The Art. 18 technical document list is indexed in review order and every claim traces to a primary source
• □ Intended-use statements are identical across the instructions for use, labeling and classification determination
• □ The power of attorney (Art. 29) is valid and the local apoderado is configured as the SIRIS submitter
• □ All submitted documents are in Spanish, or in English with official Spanish translation
• □ The schedule model is built by deficiency round, without a single 90-business-day figure
• □ Semantic reporting and UDI-DI coding under Resolución 1405 de 2022 are in place
• □ Official fees and modification fees under the 2026 fee schedule are budgeted and approved

Regulatory information verified as of October 29, 2026

All external conclusions rest on the current regulatory texts published by the competent authority, verified provision by provision before delivery.

GRZAN provides manufacturers with INVIMA standard registration support for the Colombian market, combining evidence-chain dossier architecture, classification strategy and deficiency-round timeline modeling. For inquiries, contact info@grzanglobal.com.