In Colombia, the submission of technical, scientific, and commercial documentation to health and regulatory authorities is not a mere linguistic formality: it is a legal requirement. Regulations such as Decree 4725 of 2005 (medical devices), Resolution 4002 of 2007 (Good Manufacturing Practices for medicines), Resolution 3100 of 2019 (licensing of healthcare providers), and provisions issued by the Commission for the Regulation of Medicines and Medical Devices establish that all documents filed before INVIMA or other competent authorities must be submitted in Spanish, with faithful and technically accurate translations.
At Nieto Lawyers, we combine our expertise in regulatory and health law with a team of specialized translators to ensure that your documentation complies with the strict technical standards required by law.
Documents that require official translation and technical validation
Our services cover the translation of essential documents for registration, renewal, modification, or surveillance procedures in Colombia, including:
User manuals: mandatory for medical devices, diagnostic equipment, and regulated machinery.
- Declarations of conformity: required to demonstrate compliance with national and international standards.
- Package inserts or leaflets: must faithfully reflect approved indications, contraindications, and warnings.
- Stability studies: crucial for defining shelf life and storage conditions of pharmaceuticals and cosmetics.
- IEC reports: necessary to certify electrical safety of medical equipment.
- Clinical and biocompatibility studies: basis for the approval of new devices and medicines.
- Verification and design studies: key in approval processes for high-risk products.
- Certificates of analysis: proof of compliance with technical and quality specifications.
- Commercial histories: relevant for product traceability and imports.
Risks of non-compliance with translation requirements
Submitting documents in a language other than Spanish or with inaccurate translations may result in:
- Return or rejection of dossiers by INVIMA.
- Delays of 6 to 24 months in the approval of sanitary registrations.
- Economic sanctions under Law 9 of 1979 and Decree 677 of 1995.
- Lost business opportunities and postponed market entry in Colombia.
Competitive advantage of working with Nieto Lawyers
Unlike traditional translation agencies, our service goes beyond “translating words”:
- We validate technical and regulatory terminology according to the sector (pharmaceutical, cosmetic, medical devices, agrochemical).
- We ensure regulatory consistency, so that documentation is accepted the first time.
- We integrate translation services into a comprehensive legal and regulatory package, saving time and reducing costs.
Conclusion
In Colombia, compliance with translation requirements for regulatory documents is not optional: it is a legal obligation that can mean the difference between a successful registration and a costly delay.
With Nieto Lawyers, your company gains a partner that understands both the technical language and the legal framework, ensuring your product reaches the Colombian market without setbacks.
FAQs – Technical and Regulatory Translations in Colombia
1. Is it mandatory to submit translations into Spanish before INVIMA and other authorities?
Yes. According to Decree 4725 of 2005, Resolution 4002 of 2007, and other sectoral rules, all documentation filed before INVIMA or other authorities must be in Spanish.
2. Do translations need to be official or can they be simple?
It depends on the document. Some, such as certificates of analysis or declarations of conformity, may require official or certified translation. In other cases, a technical translation validated by regulatory experts is sufficient.
3. What happens if I file documents in English or another language without translation?
INVIMA will return or reject the dossier, potentially causing delays of 6 to 24 months and sanctions under Law 9 of 1979 and Decree 677 of 1995.
4. Who should perform the translation: a translator or a lawyer?
Ideally, a specialized technical translator supervised by a lawyer with regulatory expertise, to ensure compliance and avoid rejection.
5. What technical documents usually require translation for the Colombian market?
User manuals, declarations of conformity, package inserts, stability studies, IEC reports, clinical and biocompatibility studies, verification and design studies, certificates of analysis, and commercial histories.
6. Do you only translate, or do you also support the registration process?
At Nieto Lawyers, we offer an integral service: we translate and validate documents, and we also manage registration, renewal, or modification procedures before INVIMA to secure approval on the first submission.
Does your company need to translate and validate documents to comply with Colombian regulatory requirements?
Avoid costly delays and dossier rejections. With Nieto Lawyers, your documents will be ready for approval by the authorities, with technical translations supervised by expert lawyers.
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