Importing investigational devices into Colombia for a first-in-human study: INVIMA approval, VUCE and the mistakes that delay start-up

A sponsor gets the INVIMA approval letter for a first-in-human device study in Colombia, the team celebrates, and then someone asks the question nobody planned for: how do the devices actually get into the country? In Colombia, the approval and the import are two different steps, handled by two different parts of INVIMA, and the second one has its own paperwork. I’ve seen study start dates slip because the investigational devices sat in a warehouse while the import request was corrected.

I’m Julio Martinez-Clark, CEO of bioaccess®. We run first-in-human and early feasibility device studies across Latin America, and Colombia is one of our core countries. This article explains how investigational device imports work in Colombia, what INVIMA’s own instructions require, and the mistakes I see most often.

The short answer

An investigational medical device without a Colombian sanitary registration can be imported for a clinical study only after INVIMA’s Specialized Chamber (Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro) has issued its concept approving the protocol. The importer then files an import request (registro, licencia o modificación de importación) through Colombia’s single foreign-trade window, VUCE 2.0, and INVIMA gives its visto bueno. The request must quote the approval document and match it exactly: product name, manufacturer, country of origin, presentation and the quantities INVIMA authorized. If the importer isn’t named in the approval, a letter proving its relationship with the sponsor must be attached.

Step 1: the approval comes first, and it sets the quantities

Device studies in Colombia are reviewed by INVIMA’s Clinical Research and Specialized Chamber Support Group (GICASE), created by Resolution 2022035262 of 20 September 2022. For prototype devices, the submission follows INVIMA’s checklist form ASS-RSA-FM085 and the concept request form ASS-RSA-FM172, both listed as current on INVIMA’s device clinical research page. Our INVIMA clinical trial submission checklist covers that file in detail.

What matters for the import is what the approval says. The import request can only cover what INVIMA approved, in the quantities it approved. That means the supply plan has to be in the submission, not worked out after approval. If your protocol says 15 subjects but you need spare units, sizes, accessories or replacements for devices that fail inspection, account for them in the file. Asking for more later is possible, but it adds a step you didn’t need.

Step 2: the VUCE import request

INVIMA’s instruction for import requests through VUCE 2.0, IVC-INS-IN70 (version 2, implemented 1 August 2025), has a specific section for devices used in clinical studies. When the products are imported with the prior concept and approval of the review commission or the specialized chamber, box 34 of the request (“Descripción de la mercancía”) must list:

• The number of the INVIMA act, letter (oficio) or resolution
• The date of that INVIMA document
• The specialized chamber or group that issued it
• The protocol code INVIMA assigned
• The filing number (radicado) under which the concept was requested
• The product name exactly as approved in the act, letter or resolution
• The manufacturer’s name
• The country of origin
• The commercial presentation
• The quantities, as authorized by the commission or the relevant group
• The condition of the goods, stated word for word (for example, “Mercancía Nueva”)

The same instruction adds three notes. If the importer isn’t named in the approval, a letter showing the importer’s relationship with the sponsor (the party named in the approval) must be attached electronically. Clinical research protocols, including the import request, are subject to later follow-up and control by INVIMA. And if a previous import request was denied, that has to be disclosed in the “Solicitudes especiales” box.

Where sponsors get caught

The product name doesn’t match. The import request has to use the product name as it appears in the approval. Engineering teams rename prototypes. Commercial invoices carry internal part numbers. Packing lists use a third name. If the name on the shipping documents doesn’t line up with the approval, expect questions. Pick one name in the submission and use it on the labels, invoice and packing list.

The importer isn’t who INVIMA expects. A US start-up can’t import into Colombia itself. Someone in Colombia has to be the importer of record, and that party is often not the sponsor named in the approval. That’s allowed, but only with the relationship letter. Decide who the importer is before you file the study, and if possible name it in the submission.

The quantities run out. The import can’t exceed what was authorized. Sponsors who planned only for the patients in the protocol find themselves short when a device is damaged in transit, a size is wrong or the study adds a site. Build a reasonable margin into the quantities you request at the start, and justify it.

The manufacturer or origin changes. Early-stage companies move production between a contract manufacturer and their own line, or ship from a different facility. The import request lists the manufacturer and country of origin from the approval. A change there is not a logistics detail. Talk to your regulatory team before you ship.

Shipping before the visto bueno. Devices that arrive before the import authorization is in place sit in customs. For sterile, single-use or temperature-sensitive products with shelf-life limits, that’s not only a delay but a possible loss of the batch.

Packaging and labeling for investigational devices

Investigational devices go to Colombian sites in their study packaging, not commercial packaging. The import request asks for the commercial presentation and the condition of the goods, so the packaging you describe in the submission should be what actually ships. Make sure every unit can be traced to the approval and the protocol, the labels clearly identify the product as investigational, and the shelf life is visible. If your sterile barrier or packaging validation is still being finished, plan the shipment around it. Re-labeling in Colombia is not where you want to solve that.

Biological samples going the other way

INVIMA treats the export of biological samples for clinical studies as a separate request. Its guidance on importing supplies and exporting biological samples for clinical studies (INVIMA guide) describes, for medicine studies, declaring the exports in the initial submission and filing later requests with a dedicated form. For device studies, if your protocol sends samples to a US core lab, ask the question during the submission, not when the first sample is ready to ship.

Clinical import vs commercial registration

Importing for a study does not create a sanitary registration. The VUCE instruction has a separate section for registered products, which requires the registro sanitario number, expiry and shelf life, and for products without registration but authorized by INVIMA. Investigational units can’t be sold or used outside the protocol. When you’re ready to commercialize, the device goes through a registration under Decreto 4725 of 2005, which is a different file. Our Colombia INVIMA market access page explains that route and who can hold the registration, and the market access overview compares Colombia with the rest of the region.

My checklist before you file

1. Write the supply plan into the submission: every unit, size, accessory and spare, with a margin you can justify.
2. Choose the Colombian importer before filing and, if possible, name it in the submission. If not, have the sponsor relationship letter ready.
3. Fix one product name and use it in the protocol, labels, invoice and packing list.
4. Confirm the manufacturer and country of origin won’t change before the first shipment.
5. File the VUCE request as soon as the approval document is issued, and copy the approval data into box 34 exactly.
6. Don’t ship until the import authorization is granted.
7. Check that study packaging, investigational labels and shelf life are final and match what you described.
8. If samples will leave Colombia, settle the export route during the submission.

Frequently asked questions

Do I need a Colombian sanitary registration to import an investigational device? No. Investigational devices are imported under the INVIMA clinical study approval, not under a registro sanitario. The import request must reference that approval.

Can the sponsor be the importer? The importer has to be a party in Colombia that can file through VUCE. If it isn’t the party named in the INVIMA approval, a letter showing its relationship with the sponsor must be attached.

Can I import more units than INVIMA approved? No. The import request has to match the quantities authorized. Plan for spares in the original submission.

Is the import request reviewed after the study starts? INVIMA says clinical research protocols, including the import requests, are subject to later follow-up and control.

If you’re planning a first-in-human or early feasibility device study in Colombia and want the import planned with the submission, not after it, bioaccess® can help. Start with our INVIMA approval timeline guide and the Colombia INVIMA page.