Spanish Language Compliance for INVIMA Submissions in Colombia

1. Key takeaways

Colombia’s language requirement for submissions can be summarized in one sentence: all documents submitted must be in Spanish; technical or scientific information may be submitted in English, but must be accompanied by an official Spanish translation. This is not a requirement that can be satisfied by simply translating — it determines document structure, the terminology system and the allocation of responsibility.

The GRZAN regulatory team’s judgment is that the most common form of language-compliance failure is not grammatical error but terminology inconsistency: the GMDN term entered in SIRIS, the product description in the technical file, and the Spanish names on labels and instructions for use failing to match. Resolución 1405 de 2022 lists GMDN codes and terms among the basic attributes, and on March 12, 2026 INVIMA confirmed the semantic report is fully mandatory — once terminology drifts, corrections are triggered simultaneously at the semantic report and at document review.

2. Legal basis

3. Expert insights

#### The allowance for technical or scientific information in English is an exemption that gets overused

The regulation permits technical or scientific information to be submitted in English with an official Spanish translation, and some companies use this to assemble an entirely English technical dossier with one machine translation attached. The GRZAN regulatory team cautions that the exemption applies to technical or scientific information only; legal documents — the POA, the certificate of free sale, the business license, the quality system certificate — are not covered and must be provided in Spanish. Moreover, what reviewers actually read is the Spanish text: if the Spanish translation deviates from the English original, responsibility rests with the applicant. The test is straightforward: any document carrying legal effect is Spanish without exception; any document carrying technical parameters may be bilingual, with Spanish as the master text.

#### Terminology consistency is the real battlefield of language compliance

Resolución 1405 de 2022 lists GMDN codes and terms, UDI-DI, the registration number and the issuing agency as basic attributes, manufacturer information, risk classification and special storage and packaging conditions as regulatory attributes, and the commercial description, commercial packaging units and the minimum unit of use as commercial attributes. These items must carry one identical set of Spanish wording across SIRIS, the semantic report, the technical file and the label. The GRZAN judgment is that companies should maintain a single Spanish terminology master sheet, owned exclusively by the regulatory department, with all external documents drawing their terms from it rather than naming things ad hoc at every translation round.

#### Labels, instructions for use and the patient implant card are the three mandatory checkpoints

Art. 40 requires implantable devices to provide a patient implant card (tarjeta de implante) whose content must be presented in language the end user can understand; labels and instructions for use face Colombian healthcare institutions and patients and must be in Spanish. These three items are the objects most easily sampled during on-site and post-market inspections, including the follow-up control within 15 days of issuance required by Article 57 of Ley 962 de 2005. The GRZAN regulatory team notes that once a Spanish label needs modification, it constitutes a change of a technical nature under Resolución 2025067543 at a fee of COP 1,060,243 — far more expensive than getting it right at first submission.

4. Practical recommendations

1. The GRZAN regulatory team creates a Spanish terminology master sheet unifying GMDN terms, product names, model nomenclature and packaging unit wording, owned exclusively by the regulatory department and reused company-wide.
2. Legal documents (POA, certificate of free sale, business license, ISO 13485 certificate) are provided in Spanish without exception; the English exemption is not used for them.
3. Technical files adopt an English–Spanish bilingual structure with Spanish as the master text; official translations are produced, signed and stamped by a qualified sworn translator (practical estimate), and review is based on the translation.
4. Finalize the Spanish versions of labels and instructions for use at first submission, and prepare the patient implant card for implantable devices in parallel (Art. 40).
5. Before the titular enters data in SIRIS, compare each entry against the terminology master sheet so that SIRIS, the semantic report, the technical file and the label all match.
6. Before changing the Spanish content of labels or instructions for use, assess under Resolución 2025067543 whether it constitutes a change of a technical nature and reserve the COP 1,060,243 budget.
7. Keep vigilance report wording consistent with the submission documents, and submit serious adverse events to INVIMA in proper Spanish within 72 hours of awareness.

5. Verification checklist

• □ A Spanish terminology master sheet has been created covering GMDN terms, product names, models and packaging units
• □ All legal documents have been provided in Spanish, with no reliance on the English exemption
• □ Technical files follow an English–Spanish bilingual structure with Spanish as master text, produced by a qualified sworn translator (practical estimate)
• □ The Spanish wording in SIRIS entries, the semantic report, the technical file and the label is consistent
• □ A Spanish patient implant card has been prepared for implantable devices (Decreto 4725 de 2005 Art. 40)
• □ Whether a label or instructions-for-use change constitutes a change of a technical nature has been assessed, with COP 1,060,243 reserved
• □ Vigilance reports use proper Spanish wording and the 72-hour reporting mechanism is in place (Resolución 4816 de 2008)
• □ A terminology review of semantic reports has been completed following the full mandate effective 2026-03-12 (Resolución 1405 de 2022)

Regulatory information verified as of October 29, 2026

All outward-facing conclusions are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN provides end-to-end INVIMA registration and compliance support for manufacturers entering the Colombian market, covering Spanish-language compliance, terminology governance, technical and legal documentation, SIRIS submissions and post-market vigilance. For inquiries about INVIMA registration in Colombia, contact info@grzanglobal.com.