Colombia Commercialization Permit for Controlled-Technology Equipment

1. Key takeaways

Controlled-technology biomedical equipment (equipos biomédicos de tecnología controlada) in Colombia proceeds through the Permiso de Comercialización (marketing permit), governed by Articles 23 and 24 of Decreto 4725 de 2005, standing alongside the standard registration of Article 16 and the automatic registration of Article 17 as a third, parallel form of authorization. This is not a difference in name but a difference in legal nature: registration confirms a product’s eligibility for market entry as a medical device, while the permit confirms the conditions for commercializing a specific piece of controlled-technology equipment.

On fees, the 2026 fee schedule sets the commercialization permit for controlled-technology equipment at 367.92 UVB (approximately COP 4,455,511), higher than the 364.36 UVB for Class IIb/III registration — the highest official fee among the pathways. GRZAN’s judgment: the most common error on equipment projects is planning budget and timeline as a registration at project initiation, only to discover at submission that the permit applies — at which point the organizing logic of the technical dossier and the facility and personnel requirements must all be rebuilt.

2. Legal basis

3. Expert insights

#### The divide between permit and registration comes from the word controlled

The scope provision of Decreto 4725 de 2005 (Art. 1) brings medical devices as a whole within its reach; Articles 16 and 17 handle conventional devices, while Articles 23 and 24 handle controlled-technology biomedical equipment separately. The dividing line is not risk level but technical attribute — whether the technology underlying the equipment falls within the controlled scope. GRZAN’s first action at a project kickoff for equipment is to confirm whether the device falls within the controlled-technology list; the conclusion at this step directly determines whether Articles 23/24 or Articles 16/17 apply, and with them the values in the budget and timeline models.

#### The three-pathway structure survives under the new decree

Current law runs three authorization lines in parallel: automatic registration (I/IIa), standard registration (IIb/III), and the commercialization permit (controlled-technology equipment). The draft new decree would reorganize them into a three-tier structure of notificación sanitaria, registro sanitario and permiso de comercialización, and the permiso tier is retained. This shows that the authority’s regulatory logic for controlled-technology equipment is continuous and will not loosen with a framework update. GRZAN advises equipment clients to plan long-term along the permit line and not to expect a pathway simplification from the framework switch.

#### Radiation-related requirements are stacked obligations, not part of the permit

Controlled-technology equipment involving ionizing radiation must, in addition to the commercialization permit, satisfy regulatory requirements on radiation protection and facilities (practical estimate; the specific governing provisions and processing approach follow official publications). GRZAN states its position clearly here: such requirements are additive to the Permiso de Comercialización, not alternatives to it; obtaining the permit does not waive facility and personnel conditions, and vice versa. Project schedules must model the two lines separately and never merge them into a single milestone.

#### Equipment projects bind hardest at the import and storage end

Controlled-technology equipment is mostly large-scale installations, and the weight of the landing phase is no lighter than the entry phase. The importer must hold a valid CCAA (under Resolución 4002 de 2007, valid for 5 years) and engage a technical director (director técnico); CCAA renewal inspection applications must be filed at least 5 business days before expiry. Meanwhile, the semantic standards and UDI-DI requirements of Resolución 1405 de 2022 apply to medical devices and IVD reagents, so the equipment’s coding and semantic reporting must be complete before commercialization. Equipment projects that ignore these three items cannot complete actual market placement even with the permit in hand.

4. Practical recommendations

1. At project initiation, the GRZAN regulatory team issues an authorization-form determination memo stating whether the equipment falls under the Articles 23/24 permit or the Articles 16/17 registration, and feeds the conclusion into the project budget and timeline models.
2. Before submission, the equipment manufacturer completes confirmation of controlled-technology status, with the local apoderado executing the power of attorney per Art. 29 and filing through SIRIS.
3. For equipment involving ionizing radiation, the project lead separately maps the regulatory requirements on radiation protection and facilities, confirms the processing sequence with the authority on a practical-estimate basis, and advances that line in parallel with the permit application.
4. Finance budgets the commercialization permit at 367.92 UVB on the 2026 fee schedule and reserves the technical-nature modification fee of COP 1,060,243.
5. The importer confirms a valid CCAA (5 years) and an engaged technical director, and files the renewal inspection application at least 5 business days before expiry.
6. Compliance completes the UDI-DI and GMDN semantic reporting required under Resolución 1405 de 2022 and confirms the issuing agency is within the GS1, HIBCC, ICCBBA, IFA, Ali Health or ZIIOT list.

5. Verification checklist

• □ A written determination has been issued that the equipment falls under the Articles 23/24 permit rather than the Articles 16/17 registration
• □ Controlled-technology status has been verified, with the basis traceable to the regulatory text
• □ For ionizing radiation, radiation protection and facility requirements are listed separately and the processing sequence is confirmed
• □ The power of attorney (Art. 29) is valid and the local apoderado is configured as the SIRIS submitter
• □ The 367.92 UVB permit fee and modification fees under the 2026 fee schedule are budgeted and approved
• □ The importer’s CCAA is valid, a technical director is engaged, and the renewal inspection date is scheduled
• □ UDI-DI and GMDN semantic reporting is complete, with the issuing agency on the recognized list

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 supports manufacturers of controlled-technology biomedical equipment in the Colombian market with INVIMA commercialization permit strategy, classification determinations and import-readiness planning. For inquiries, contact info@grzanglobal.com.