Apostille and Official Translation of Registration Documents for Colombia

1. Key takeaways

For registration documents issued abroad to be accepted by INVIMA, two things must happen: the documents themselves must be legalized, proving that issuance and signature are genuine, and their content must be rendered into Spanish. These two steps follow a strict order, legalization first and translation second. Reversing the order strips the translation of a traceable original and effectively forces the whole set to be redone.

The GRZAN position is that the legalization chain is the only step that cannot be remedied inside Colombia. Technical documentation can be repaired locally, but foreign notarization and apostille must be handled back in the country of origin, and the deficiency response period is only 90 days, with a single unanswered deficiency treated as a procedural suspension. Scheduling legalization as the last step of the project is the most common fatal mistake in this module.

2. Legal basis

3. Expert insights

#### 1. Legalization answers who signed the document, not what the document says

Notarization and apostille attest to the identity of the signatory, the act of signing and the authenticity of the issuing body’s seal. They do not review content and they do not prove product compliance. Both the People’s Republic of China and Colombia are parties to the Convention Abolishing the Requirement of Legalisation for Foreign Public Documents, the Hague Apostille Convention, so foreign public documents bearing an apostille can be used directly in Colombia without the consular legalization route (practical estimate; the accepting authority and specific handling requirements follow the current announcements of the two countries’ competent authorities). GRZAN stresses this because projects still occasionally repeat consular legalization on top of an apostille, adding weeks of delay for no legal benefit whatsoever.

#### 2. Translation must follow legalization, and it must cover the whole document

All submission documents must be in Spanish; technical or scientific information may be submitted in English provided it carries an official Spanish translation. Legalization attests to the original document, so if the translation is made first and the apostille applied afterward, the apostille attests to the translation and the reviewer can no longer trace the rendering back to the legalized original. GRZAN requires the translation to cover the entire document, including headers, seal and signature annotations, annex lists and table titles. Partial translations that render only the body paragraphs are among the highest-frequency findings in deficiency notices, and each one consumes part of the 90-day window.

#### 3. The 90-day deficiency period forces legalization to be scheduled in front

The deficiency response period is 90 days, and a single failure to respond is treated as a procedural suspension. The real duration of foreign notarization and apostille is not controlled by the applicant; it depends on registries, notaries and competent authorities abroad. If legalization is started only after the technical documentation is complete, and the reviewer then raises an objection to the legalization of one legal document during the deficiency stage, the remaining time is rarely enough to complete a full cross-border round. The correct approach is to lock the list of documents requiring legalization at project initiation and start processing them immediately.

#### 4. The certificate is valid for 10 years, and the expiry of legalized documents must be managed in step

The medical device registration certificate is uniformly valid for 10 years, counted from the date of the administrative act granting it. Where the validity of a power of attorney or similar legal document is shorter than the certificate’s term, an authorization vacuum appears mid-term, and since Art. 20 requires the certificate to state the name and address of the titular, any change of entity information drags the legal-nature change channel into play. GRZAN recommends back-calculating the term of authorization documents from the certificate’s validity, so that no renewal of a legalized document is ever needed under time pressure in the middle of the certificate’s life.

4. Practical recommendations

1. Have GRZAN issue the list of documents requiring legalization at project initiation, separating corporate entity documents from authorization documents and specifying the competent authority for each.
2. Have the foreign manufacturer process documents in the order of notarization first and apostille second, and send them for official translation only after legalization; never translate before signing and legalization are complete.
3. Have the translation agency produce the full Spanish rendering, covering headers, seal and signature annotations, annex lists and table titles, together with a translator qualification statement.
4. Have the registration specialist check, before upload to SIRIS, that the apostille number, the apostille page and the original are bound as a single document for every file.
5. Have the local legal representative verify that the name and address of the titular in the translations match the items required under Art. 20 word for word.
6. Have GRZAN maintain an expiry ledger for legalized documents, back-calculating authorization document terms from the 10-year validity of the certificate.

5. Verification checklist

• □ The list of documents requiring legalization was locked at project initiation and processing has started
• □ Notarization and apostille are complete, in the order of notarization first and apostille second, with no repeated consular legalization
• □ Translation was performed after apostille, and every rendering traces back to the legalized original
• □ Translations are complete-document renderings covering headers, seal annotations, annex lists and table titles
• □ The apostille number, apostille page and original are bound as one document
• □ The titular name in the translations matches the items required under Art. 20 word for word
• □ A countdown ledger for the 90-day deficiency response period is in place

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 legalization planning, apostille coordination in the country of origin, official Spanish translation management and deficiency-cycle control before INVIMA. For inquiries, contact info@grzanglobal.com.