Who Must Hold the Medical Device Registration in Colombia

1. Key takeaways

A foreign manufacturer may hold a Colombian medical device registration certificate in its own name. Article 3 of Decreto 4725 de 2005 defines the titular as an independent role, and Article 20 requires the certificate to state the name and address of the titular – the name on the certificate is the holder itself, not an intermediary that merely runs the process. Holding the certificate and filing the application, however, are two different matters: a foreign entity has no Colombian legal or tax identity, so the actual submission must still be completed by a local apoderado in SIRIS. GRZAN’s position is that the titular determines who owns the certificate, while the apoderado determines how quickly it is obtained; the two roles should be designed separately and contracted separately.

Placing the certificate in the name of a local distributor looks convenient, but the cost surfaces at exit: a change of the registered entity is a change of legal nature, priced at COP 826,546 under Resolución 2025067543, and it also requires cooperation documents from both parties. When the certificate is held in the name of the Chinese manufacturer itself, changing a business partner only means replacing the apoderado; the registered entity stays untouched. A device registration certificate is valid for 10 years, and each renewal appends an R suffix counter to the registration number (format example INVIMA 2025DM-0002510-R2). This is a ten-year asset arrangement and should not be given away during price negotiations.

2. Legal basis

3. Expert insights

#### The titular is the asset owner, not whoever runs the process

Decreto 4725/2005 defines the titular, the fabricante and the importador as three separate roles, which shows that the legislator deliberately anticipated that the three need not be the same entity. When a foreign manufacturer holds the certificate itself, the titular and the fabricante coincide; when a local partner holds it, the three roles belong to three different parties. Whether the roles overlap directly determines which channel every future change must take – changing the titular is a change of legal nature, while changing technical content is a change of technical nature; the two channels carry different official fees (COP 826,546 versus COP 1,060,243) and different depths of review.

#### The true cost of partner-held registration appears at the breakup

In the disputes GRZAN has handled, the most common outcome is not a rejected registration but a certificate that was granted and then cannot be recovered. When the distributor acts as titular, the manufacturer is only the fabricante, and the certificate reflects no asset claim by the manufacturer. Once the relationship breaks down, the manufacturer must either file a fresh application (going through the 2 business days automatic registration or the 90 business days standard registration again) or pay for a change of registered entity. Because the Colombian market depends on imports for roughly 80%–85% of its supply, local partners understand their leverage, and the negotiating position is naturally asymmetric.

#### Over a ten-year cycle, self-holding has the lower marginal cost

Self-holding requires one POA and one local apoderado, both routine legal instruments; partner-held registration stakes the entire certificate. Judging by the INVIMA registration database, which holds roughly 423,000 IVD and device records, of which Chinese manufacturers account for about 14.4% (third-party statistics), the certificates Chinese companies hold in Colombia are no longer a handful of isolated filings but a systematic asset portfolio – all the more reason to hold them under a unified structure.

4. Practical recommendations

1. Legal counsel of the Chinese manufacturer: determine the titular before the first submission; in principle it should be the manufacturer itself or a legal entity it establishes in Colombia, and it should not be ceded to a channel partner.
2. GRZAN regulatory team: limit the scope of the apoderado in the Art. 29 power of attorney – authorize only submission, deficiency responses and collection of the certificate, never disposal of the registration.
3. Commercial lead: include a dedicated registration ownership clause in the distribution agreement, stating that the titular of the certificate is the manufacturer and the distributor obtains only the right to sell.
4. Registration specialist: verify that the name and address of the titular on the certificate draft match exactly the manufacturer’s business license and the POA.
5. Project management: maintain a certificate ledger recording the registration number, grant date, expiry date and renewal count (R suffix), and start renewal 3 months before expiry.

5. Verification checklist

• □ The titular field of the certificate names the manufacturer itself or its designated entity, matching the business license
• □ The POA has been issued under Art. 29 and completed the required authentication and Spanish translation
• □ The POA excludes the apoderado’s power to transfer, waive or dispose of the registration certificate
• □ The distribution agreement states that registration ownership rests with the manufacturer and the channel party holds only sales rights
• □ A contingency budget of COP 826,546 for a change of legal nature has been calculated
• □ The certificate ledger records the 10-year validity and the renewal window 3 months before expiry
• □ If a partner holds the certificate, its written commitment to cooperate in a future transfer of the registered entity has been obtained

• 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 supports manufacturers entering Colombia with local licensed-entity and importer structuring, apoderado and POA arrangements, and full fee budgeting under the 2026 Manual Tarifario. Whether you need to define who should hold the INVIMA registration, negotiate ownership clauses with distributors, or estimate the complete cost of registration and future changes, our regulatory team can provide a tailored plan for the Colombian market. Contact us at info@grzanglobal.com.