Decreto 4725 Article 19: Legal Dossier, Local Representative and POA

1. Key takeaways

Colombia does not recognize a foreign manufacturer’s direct filing eligibility. A foreign manufacturer must appoint a local legal representative in Colombia (apoderado or representante legal), and it is that representative who files the application with SIRIS as the titular. Every link in this delegation chain needs legal documentation in the sense of Article 19, while Article 29 regulates the power of attorney (POA) itself as a distinct subject.

The GRZAN position is that legal documents are the only module where an error forces a restart of the procedure and cannot be repaired by a technical explanation. Missing technical items can be supplemented; a broken authorization chain often means the certificate must be reissued from scratch. Under the current fee schedule, a change of legal nature costs COP 826,546, and that figure excludes the time consumed by renewed notarization and legalization abroad.

2. Legal basis

3. Expert insights

#### 1. The three identities under Art. 3 cannot be mixed, and mixing them is the root cause of broken delegation chains

Article 3 defines the dispositivo médico, the titular, the fabricante and the importador as distinct subjects. The titular is the holder and applicant of the registration certificate, the fabricante is the manufacturer, and the importador is the importer. Foreign manufacturers frequently wish to act as the titular themselves; in Colombia this does not work, because without a local legal representative there is no filing channel at all. GRZAN requires the three roles to be fixed in writing at project initiation, together with a clear statement of which party bears the vigilance and recall obligations. Projects that postpone this allocation routinely discover the gap only after submission, when the roles cannot be changed without touching the legal nature of the certificate itself.

#### 2. Article 29 regulates the power of attorney separately, which means it is treated as an independent risk point

Beyond the legal document list of Art. 19, the decree dedicates Art. 29 to the power of attorney. The drafting message is that the scope of authorization, the validity period and the signatory’s capacity are examined on their own. A POA that merely states authority to handle the registration cannot cover subsequent changes, renewals and vigilance duties, while the registration certificate is valid for 10 years. A short authorization will expire in mid-term of the certificate, leaving the holder without a valid mandate exactly when a change or renewal must be filed, and restoring the mandate requires a new legalized document from abroad.

#### 3. The delegation chain must be traceable all the way up to the manufacturer entity

A typical chain runs from the foreign manufacturer to a regional headquarters, then to a local importer, and finally to the local legal representative. Each additional layer requires its own authorization or distribution agreement. GRZAN holds that the fewer layers the better: every document in the chain must prove that its signatory had the power to sign, and for foreign entities the proof of signing authority usually traces back to the registry filings of the company’s place of incorporation. Chains assembled loosely fail exactly where reviewers start checking, at the connection between two consecutive documents.

#### 4. The cost of changes forces sufficient margin into the first authorization

A change of legal nature costs COP 826,546 and a change of technical nature COP 1,060,243 under the current fee schedule. Changes to the name or address of the titular fall into the legal-nature category, so once the name and address stated under Art. 20 no longer match reality, the paid change channel is the only way through. Writing the scope of authorization generously at first submission is far cheaper than correcting it afterward through a formal change procedure, and it also avoids the notarization and translation loop that every corrected POA must repeat.

4. Practical recommendations

1. Have the foreign manufacturer’s legal counsel issue proof of the signatory’s capacity, stating the name, position and corporate registration details of the authorized signatory, so that the POA is not returned over doubtful signing authority.
2. Have GRZAN draft the Spanish original of the POA with a scope covering registration applications, changes, renewals, vigilance reporting and recall cooperation, with a term covering the 10-year validity of the certificate plus a margin for renewal.
3. Have the local legal representative verify, before submission in SIRIS, that the name and address of the titular required under Art. 20 match the business license or commercial registry record word for word.
4. Have the importer confirm its CCAA status in parallel, because an importer must hold a valid storage and adaptation capacity certificate to actually clear customs.
5. Have GRZAN maintain an expiry ledger for authorization documents and start the reissuance of a POA before it lapses, so that no authorization vacuum appears during the validity of the certificate.
6. Have the applicant budget COP 826,546 for a change of legal nature under the current fee schedule whenever a titular change occurs, and reserve time for notarization and translation.

5. Verification checklist

• □ The identities and obligation boundaries of the titular, fabricante and importador are defined in writing
• □ The POA is a Spanish original, and the signatory’s capacity is supported by corporate registry documents
• □ The POA scope covers changes, renewals and vigilance duties, not merely handling the registration
• □ The POA term covers the 10-year validity of the registration certificate
• □ Every layer of the delegation chain carries an authorization or distribution agreement, with no broken link
• □ The name and address of the titular match the requirements of Art. 20 word for word
• □ The importer’s CCAA is within its validity period
• □ The change fee of COP 826,546 for legal-nature changes is included in the change contingency budget

Regulatory information verified as of October 29, 2026

All conclusions for external use are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN supports manufacturers entering the Colombian market with registration dossiers and conformity documentation, including legal dossier preparation under Art. 19, POA drafting and legalization coordination, representative arrangements and change management before INVIMA. For inquiries, contact info@grzanglobal.com.