Titular, Fabricante and Importador Roles in Colombian Registration

1. Key takeaways

On a single Colombian registration certificate, the titular, the fabricante and the importador can all appear and all differ from one another. Article 3 of Decreto 4725 de 2005 defines the three roles separately, and Article 20 only requires the certificate to state the name and address of the titular; nothing demands that the three roles be combined in one entity. GRZAN’s assessment is that the three roles may sit in three different companies, but they must interlock on the documentation chain – the POA connects the titular with the local representative, and the commercial invoice and authorization connect the fabricante with the importador.

Conflicts usually arise not from the law itself but from inconsistent documents: the fabricante name on the certificate differs from the free sale certificate or the ISO 13485 certificate, or the importer name differs from the CCAA holder. When such inconsistencies are questioned at customs clearance or during market inspection, the cost of explaining them far exceeds the cost of unifying the names before submission. The validity periods of the certificates each role depends on are also out of sync – the registration certificate lasts 10 years and the CCAA lasts 5 years – so whenever any role changes hands, the corresponding certificates must be checked for continued validity, not just the registration certificate itself.

In practice, the review of these three roles happens twice: once before submission, when the role matrix is drawn up and every document is aligned to it, and once after any role change, when the entire chain must be re-verified. Companies that skip the first review almost always pay for the second under time pressure, with a shipment or a deficiency notice already on the table.

2. Legal basis

3. Expert insights

#### Separation of the three roles is legal; consistency across the three is necessary

The law permits separation, but the competent authority judges credibility by whether the documentation chain is self-consistent. Four sets of materials – the registration certificate (titular information), the technical file (fabricante information), the import documents (importador information) and the CCAA (holder of storage capability) – must align; if any two names or addresses fail to match, inspectors will ask who is accountable for the device. GRZAN’s method is to draw a role matrix first, then make every document follow the matrix wording.

#### Resolución 1405 turns manufacturer information into a structured field

Resolución 1405 de 2022 lists manufacturer information as a regulatory attribute, alongside the UDI-DI, the GMDN code and the risk classification, and INVIMA confirmed by official communication on March 12, 2026 that semantic reporting is now fully mandatory. This means the fabricante name is no longer free text: once it conflicts with the record in the UDI database, that is a hard, data-level conflict, and fixing it requires going through the change channel.

#### The importer and the CCAA holder should be one and the same

The importer must hold a valid CCAA; the CCAA is valid for 5 years, requires an employed technical director (director técnico), and must be renewed by applying for re-inspection at least 5 business days before expiry (public INVIMA guidance). If the importador on the certificate, the actual customs declarant and the CCAA holder are three different companies, any shipment can stall at the storage-qualification step. GRZAN recommends that these three be the same entity.

4. Practical recommendations

1. Registration specialist: build a role matrix before submission, listing the legal names and addresses of the titular, fabricante and importador.
2. Manufacturer quality department: confirm the names on the ISO 13485 certificate and the free sale certificate match the fabricante in the application exactly.
3. GRZAN regulatory team: verify the manufacturer information field in the UDI-DI records matches the registration application, avoiding conflicts at the semantic reporting stage.
4. Importer: confirm your CCAA is valid and the CCAA holder name matches the header of the customs documents.
5. Legal counsel: state in the POA the relationship between the titular and the importer, preventing the importer from claiming ownership of the certificate.
6. Project manager: whenever a role changes, assess in parallel whether the change of legal nature (COP 826,546) or the change of technical nature (COP 1,060,243) applies.

5. Verification checklist

• □ The role matrix is complete, with unified legal names and addresses for the three roles
• □ The titular name on the certificate matches the POA and the business license
• □ The fabricante name matches the ISO 13485 certificate and the free sale certificate
• □ The fabricante name matches the manufacturer information field in the UDI-DI records
• □ The importador name matches the CCAA holder and the customs document header
• □ The CCAA is within its 5-year validity and the re-inspection application is scheduled
• □ The fee channel for role changes has been estimated and budgeted

• GRZAN regulatory team

Regulatory information verified as of October 29, 2026

All conclusions published here are based on the current regulatory texts issued by the competent authority and are verified item by item before delivery.

GRZAN helps manufacturers structure the titular, fabricante and importador roles for the Colombian market, align every document in the chain, and budget the fees for registration and future changes, including local licensed-entity and importer support. For a role-consistency review before you file, contact us at info@grzanglobal.com.