You already hold an INVIMA registro sanitario in Colombia. The titular is not changing. What is changing is the importer: a distributor is leaving, a new one is coming in, or you want a second importer next to the first. Can you just tell the new partner to start bringing in product? Do you need a new registration? How long does it take?
Sponsors send me this every few weeks, usually after the commercial decision is made. I’m Julio Martinez-Clark, CEO of bioaccess®. We help medical device companies with first-in-human studies and market access across Latin America, and in Colombia we act as registration holder and importer of record through our own Colombian entity. This article covers what Decreto 4725 de 2005 and Decreto 582 de 2017 actually say about an importer change, what the titular files, and the three things that slow it down in practice.
The short answer
An importer change is a modification of the registro sanitario, not a new registration and not a courtesy letter to INVIMA. The importer’s name and address are part of the content of the registration itself. Under Decreto 4725 de 2005 Art. 30, as replaced by Decreto 582 de 2017, modifications are processed automatically, with later review of the supporting documents (revisión posterior). The titular files the request; the new importer has to qualify on its own, including a valid CCAA (Certificado de Capacidad de Almacenamiento y Acondicionamiento). Until the modification is granted, the new company is not the importer named on your registration.
Keep it separate from a change of titular. If the holder itself is changing, that is a cesión, done through a modification for change of titular, and it carries a different risk profile. See how to transfer a medical device registration to a new holder for that path.
Why the importer is part of the registration
Decreto 4725 de 2005 Art. 20 lists the minimum content of every registro sanitario for devices that are not controlled technology. Next to the DM number, the validity, the titular, the product name, the manufacturer, the risk class and the authorized models, literal (j) is “nombre y domicilio del importador.” Art. 25 does the same for the permiso de comercialización of controlled-technology biomedical equipment (literal f).
Sponsors think of the importer as a commercial partner. INVIMA treats the importer as a named field of an administrative act. If the field changes, the act has to be modified. That is also why a change in the existing importer’s registered address is handled as a modification and not as a note to the file.
What Decreto 582 de 2017 changed
Decreto 582 de 2017 Art. 2 replaced Art. 30 of Decreto 4725 with an automatic procedure: INVIMA issues the modification within the term in Art. 22 literal (b), and then reviews the supporting documents afterwards. The applicant fills in INVIMA’s modification form and attaches the technical and/or legal documents that support the change. INVIMA can approve a modification when the change does not affect the safety and effectiveness of the device.
An importer change is a legal modification. Nothing about the device changes. That is the kind of change the automatic route was written for. The Art. 30 paragraph that blocks modifications (significant changes in design, material composition, energy source or manufacturing process) is not what applies here.
The part sponsors skip is Art. 3 of Decreto 582: revisión posterior. After granting the modification, INVIMA checks the requirements. If something is missing, it asks once, and the titular has 90 days to answer. If the answer does not arrive or is unsatisfactory, INVIMA suspends the registro sanitario. If three months pass after the suspension is notified without a satisfactory answer, the registration is cancelled. “Automatic” means approved first and examined later. It does not mean unexamined. A weak importer file can put the whole registro at risk, not just the new importer.
What the new importer has to bring
The titular files, but the new importer’s paperwork decides whether the file holds up at revisión posterior. On the projects I see, the file usually needs:
- A valid CCAA. Decreto 4725 Arts. 10 and 11 require importers and sellers of medical devices to meet storage and conditioning requirements, and INVIMA issues the CCAA to show it. The CCAA has to be in force and cover the type of product. An importer with a CCAA for a different product line has to confirm coverage before you file.
- Existence and legal representation. The certificate from the Cámara de Comercio, with a corporate purpose (objeto social) that covers import and sale of medical devices. A partner that is fine commercially but has a narrow objeto social is one of the most common reasons a file stalls.
- The manufacturer’s or titular’s authorization naming the new importer for the specific registration(s), with the legalization or apostille the document needs. See our note on apostille and legalization for device registration.
- INVIMA’s modification form, filled in for each registration being modified, plus payment of the legal-modification tariff in INVIMA’s current Manual Tarifario. Each registro is its own modification. A portfolio of twelve registrations means twelve filings.
Removing the outgoing importer is the other half. Decide whether you are adding an importer (both stay named) or replacing one (the old one comes off). Colombia allows more than one importer on a registro, which is a useful way to bring in a new partner before the old relationship formally ends.
The three things that actually slow it down
1. The registration is held by the outgoing distributor. If the distributor is the titular, an importer change is not something you control. You need the titular to file it, or you need a change of titular first. See registration holder vs distributor: the license should not be the channel. If your registro sits with the partner you are leaving, start the holder conversation before the commercial notice goes out.
2. Labels. Decreto 4725 Art. 54 requires the container label to carry, in Spanish, the manufacturer and/or importer with address. Change the importer and you change the Colombian label or sticker. Stock already in the country under the old importer’s name needs a plan agreed with your regulatory team before the switch, and the new importer’s label artwork needs to be ready for the first shipment it receives.
3. Timing against renewal. Art. 32 requires the renewal to be filed three months before the registro expires, or it is processed as a new application. If an importer change and a renewal land in the same quarter, sequence them on purpose. I would rather file the importer modification early than discover at renewal that the importer field is out of date.
How I’d brief a sponsor switching importers in Colombia
Take a US-based manufacturer of a Class IIb device with one INVIMA registro, an exclusive distributor who has been the importer for four years, and a new partner ready to take over. The brief looks like this:
- Read the registro first. Confirm who the titular is, the modality, the models, the expiry date and the importer currently named. If the distributor is the titular, stop and plan the holder question first.
- Qualify the new importer before filing. CCAA in force and covering the product type, Cámara de Comercio certificate with the right objeto social, legal representative identified.
- Choose add or replace. Adding the new importer first and removing the old one later lowers the risk of a gap in supply.
- File one modification per registro through INVIMA with the legal documents attached, and build the evidence index as if it will be read at revisión posterior. It will be.
- Release the new label artwork with the new importer’s name and address, and agree the plan for stock already in the country.
- Update the post-market side. Tecnovigilancia contacts, complaint routing and recall roles often sit with the importer in practice. The obligations sit with the titular. See INVIMA tecnovigilancia obligations for the registration holder.
How this compares with Mexico
The COFEPRIS logic is similar (the importer or distributor is tied to the registration record, so a change is a filing), but the procedure and timing differ. See does changing the distributor or importer delay a COFEPRIS application?
Operator checklist
- Pull every registro sanitario that names the outgoing importer, and confirm the titular on each.
- Confirm the new importer’s CCAA, objeto social and legal representative before you pay any tariff.
- File one legal modification per registro under Decreto 4725 Art. 30, as replaced by Decreto 582 de 2017.
- Calendar the 90-day window for any INVIMA request at revisión posterior.
- Release Spanish label artwork with the new importer, and check Art. 32 renewal dates.
Bottom line
In Colombia, changing the importer on an existing INVIMA registro sanitario is a legal modification of the registration, because the importer’s name and address are part of the registration (Decreto 4725 Art. 20 j). Since Decreto 582 de 2017 it is granted automatically and reviewed afterwards, and a file that fails revisión posterior can lead to suspension and then cancellation. The new importer needs its own CCAA and the right corporate purpose. The label changes with it. And if your distributor is also the titular, the importer change is the second problem, not the first.
Planning an importer change across a Colombian portfolio? Our Colombia INVIMA market-access page and the regional bioaccess® market access hub explain how we hold registrations independently of the distribution channel, so a commercial change does not have to become a regulatory one.
Sources: Decreto 4725 de 2005 (Arts. 10, 11, 20, 25, 27, 30, 32, 54) and Decreto 582 de 2017 (Arts. 2 and 3), INVIMA normograma; INVIMA device FAQ. This article is general regulatory information, not legal advice; confirm the current INVIMA form and tariff before filing.