Electrical Safety, EMC and the Biomedical Equipment Permit Route

1. Key takeaways

Controlled-technology biomedical equipment (equipos biomédicos de tecnología controlada) does not enter the Registro Sanitario channel; it applies for a Permiso de Comercialización (marketing permit) under Articles 23 and 24 of Decreto 4725 de 2005. This distinction decides the dossier structure: the permit reviews the safety and suitability of the equipment in its specific use environment, and electrical safety and electromagnetic compatibility are the core indicators within that review.

Under the current 2026 fee schedule, the marketing permit for controlled-technology equipment is 367.92 UVB, approximately COP 4,455,511, slightly above the 364.36 UVB for Class IIb/III registration. That fee schedule was established by Resolución 2025067543 (published December 22, 2025) and partially amended by Resolución 2026033499 (June 30, 2026), so any budget built on an older table is already wrong.

2. Legal basis

3. Expert insights

#### 1. The divide between the permit route and the registration route lies in regulatory logic, not in the price of the equipment

The Registro Sanitario addresses market access for the product itself; the Permiso de Comercialización addresses the permit to place controlled-technology equipment into use. GRZAN’s judgment is that the most common consequence of preparing a controlled equipment dossier under the registration route is not outright rejection but a deficiency demanding equipment-level operating and installation condition documents, wasting an entire deficiency cycle. The route decision must be brought forward to project initiation, with the classification conclusion under Art. 6 and Art. 7 and the technical attributes of the equipment as its basis. The permit route asks different questions, and a dossier structured around the wrong questions cannot answer the right ones without rebuilding.

#### 2. Electrical safety and electromagnetic compatibility must answer how the equipment is used in Colombia

Electrical safety material that only proves conformity with a standard, without explaining the applicability boundaries under local grid conditions, installation environments and use scenarios, gives the reviewer no basis to judge risk. GRZAN requires the answer to be split into three layers: conformity evidence, being the name and version of the standards relied upon; boundary conditions, being supply, earthing and environmental limitations; and use constraints, being prohibited combinations and restrictions on adjacent equipment. Only with all three layers in place are the technical indicators truly answered, and only then can the reviewer conclude that the equipment is safe in the environment where it will actually operate.

#### 3. Standard versions must be stated; a citation without a version equals no citation

The current decree does not designate specific standard versions at the article level (practical estimate). A recurring failure GRZAN sees in projects is a report stating only conformity with the relevant electrical safety standards, without names or versions, leaving the reviewer unable to verify and no option but a deficiency. Writing the standard names, versions and an applicability note onto the first page of the report costs almost nothing, and the return is one full deficiency round saved, which in a permit procedure means weeks of schedule and one less consumption of the reviewer’s patience.

#### 4. The fee structure must be checked against the current table, distinguishing permit from changes

The fee schedule has already been partially amended once within 2026, so budgeting on the old table produces errors. The marketing permit for controlled-technology equipment is 367.92 UVB; a change of technical nature is COP 1,060,243 and a change of legal nature COP 826,546. GRZAN recommends including change fees in the budget from the start, because controlled equipment has a high probability of triggering technical-nature changes during the life of the permit as configurations, accessories or software versions evolve, and an unbudgeted change stalls the equipment’s deployment exactly when it is needed in the field.

4. Practical recommendations

1. Have GRZAN determine at project initiation, under Art. 6 and Art. 7, whether the equipment falls within controlled-technology biomedical equipment and set the route as the permit of Art. 23 and Art. 24.
2. Have the foreign manufacturer provide the electrical safety and electromagnetic compatibility test reports, stating the standard names, versions and applicable clauses.
3. Have the technical director supplement the boundary conditions statement, specifying supply, earthing and environmental limitations and the prohibited equipment combinations.
4. Have the local legal representative complete the official Spanish translation of all materials before submission in SIRIS, with no technical indicator or unit left untranslated.
5. Have the applicant budget the permit fee of 367.92 UVB under the current fee schedule and reserve COP 1,060,243 for a technical-nature change.
6. Have the quality lead establish the post-deployment vigilance channel for the equipment, ensuring serious adverse events are reported to INVIMA within 72 hours.

5. Verification checklist

• □ The equipment is confirmed as controlled-technology biomedical equipment, with the route set as Permiso de Comercialización
• □ The electrical safety and electromagnetic compatibility reports state standard names, versions and applicable clauses
• □ The boundary conditions statement is provided: supply, earthing, environmental limitations and prohibited combinations
• □ All materials carry an official Spanish translation, with no technical indicator or unit missing
• □ The permit fee of 367.92 UVB is budgeted under the current 2026 fee schedule
• □ The technical-nature change fee of COP 1,060,243 and the legal-nature change fee of COP 826,546 are in the change contingency plan
• □ The 72-hour serious adverse event reporting channel is established

Regulatory information verified as of October 29, 2026

All conclusions for external use are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN supports manufacturers entering the Colombian market with registration dossiers and conformity documentation, including route selection for controlled-technology biomedical equipment, electrical safety and EMC evidence packaging, fee budgeting under the 2026 schedule and vigilance channel setup before INVIMA. For inquiries, contact info@grzanglobal.com.