Colombia Customized Devices and Controlled Technology Pathways

1. Key takeaways

Colombia has two pathways that are chronically misread. The first is customized devices (dispositivos sobre medida): Art. 1 of Decreto 4725 de 2005 excludes them from the scope of application, so they cannot obtain a Registro Sanitario and are not subject to the I/IIa/IIb/III classification. The second is biomedical equipment involving controlled technology: it goes through the Permiso de Comercialización (marketing permit), with its legal basis in Art. 23 and Art. 24, producing a permit rather than a registration certificate, at a fee of 367.92 UVB (approximately COP 4,455,511) — higher than the 364.36 UVB for Class IIb/III device registration.

The GRZAN regulatory team’s judgment is that misreading these two pathways costs far more than an ordinary submission. Misreading the customized device rules causes an application to be rejected at formal screening; misreading controlled-technology equipment causes companies to prepare materials as if for a registration certificate, select the wrong fee tier, and ultimately receive a document that does not match their actual business needs.

2. Legal basis

3. Expert insights

#### Excluding customized devices reflects a failed evaluation object, not lower requirements

Customized devices are made to an individual patient’s prescription or anatomical data and lack the batch-standardized evaluation object that registration presupposes — there is no stable model and no reproducible performance batch, so a registration system premised on product families cannot be applied. Art. 1 excludes them as a matter of logic, not of regulatory relaxation. The GRZAN regulatory team cautions that exclusion must not be read as exemption: customized devices remain subject to health surveillance in distribution, use and vigilance, and once a product is found to be batch-produced it must return to the ordinary registration pathway. The determining question is whether production depends on the individualized data of a single patient — it has nothing to do with the technical sophistication of the product.

#### The Permiso de Comercialización and the Registro Sanitario are authorizations of different natures

The Registro Sanitario targets the product itself, confirming that a given model may circulate on the market; the Permiso de Comercialización targets the commercialization of biomedical equipment involving controlled technology, with the regulatory focus on conditions of use and the operating environment. The two occupy different entry points in SIRIS, with different document lists and different fee schedules. The GRZAN judgment is that companies must determine at the product-selection stage whether the equipment falls within controlled technology, because once the wrong entry point is chosen, fees already paid do not transfer automatically, and the correction reply period is only 90 days (practical estimate: public sources vary between calendar days and business days), after which the application is treated as suspended.

#### Vital no disponibles is a third, narrow channel

Art. 48 establishes a special import authorization for vital no disponibles — devices of major importance for which no alternative exists domestically — covering situations where Colombia has no substitute product and the clinical need is genuine. The channel applies narrowly, but it is not rare in real demand arising from emergency care, rare diseases and frontier-technology products. The GRZAN regulatory team recommends treating it as a fallback plan alongside the registration certificate rather than activating it in haste only when clinical need becomes imminent.

4. Practical recommendations

1. The GRZAN regulatory team determines at project initiation whether the product is a customized device: if production depends on the individualized data of a single patient, it stays outside the ordinary registration pathway, and the health surveillance requirements for distribution and use are confirmed in parallel.
2. For product lines that may contain both standard models and customized models, manage the two separately, so a customized model is not retroactively found to be batch-produced with corrective rework.
3. For biomedical equipment involving controlled technology, use the Permiso de Comercialización entry under Art. 23 and Art. 24 and prepare commercialization-condition materials; do not reuse the registration lists of Art. 18 and Art. 19.
4. Confirm the fee tier under Resolución 2025067543 at 367.92 UVB (approximately COP 4,455,511), kept distinct from the Class IIb/III device registration fee.
5. Have the titular verify in SIRIS that the chosen entry point matches the product attributes, completing an entry re-check before payment.
6. For products qualifying as vital no disponibles, assess the feasibility of the Art. 48 special import authorization and prepare a statement of clinical necessity.
7. Once a correction notice is issued, have the titular respond within the reply period; a single missed correction results in suspension, and recovering from suspension costs more than answering on time.

5. Verification checklist

• □ It has been determined whether the product is a customized device (dispositivos sobre medida)
• □ If customized, it has been confirmed that the registration pathway of Decreto 4725 de 2005 does not apply, and distribution and vigilance obligations have been confirmed
• □ It has been determined whether the product is biomedical equipment involving controlled technology
• □ If so, the Permiso de Comercialización entry under Art. 23 / Art. 24 has been selected
• □ The fee tier has been confirmed at 367.92 UVB (approximately COP 4,455,511)
• □ The entry point selected in SIRIS, the product attributes and the fee tier are consistent
• □ The applicability of the Art. 48 vital no disponibles special import authorization has been assessed
• □ A tracking mechanism for correction reply deadlines has been established (reply period 90 days, practical estimate)

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 pathway determination for customized and controlled-technology products, SIRIS submissions, fee verification and post-market obligations. For inquiries about INVIMA registration in Colombia, contact info@grzanglobal.com.