When language delays a regulatory approval
A company has spent months preparing its submission, technical documentation, certifications, validations, everything is ready.
The dossier is submitted, and the process stalls.
Not because of a technical issue.
Not because the product fails to comply.
But because of something often underestimated: the language of the dossier.
In Costa Rica, the Ministry of Health has made it clear: all documents submitted in regulatory procedures must be in Spanish or accompanied by the appropriate translation.
What may seem like an administrative detail can quickly become a critical compliance factor.
Not all translations are the same
One of the most common mistakes in regulatory submissions is assuming that any translation will do.
It will not.
Regulations clearly distinguish between:
- Official translations, required for legal or official documents such as certificates, powers of attorney, or contracts
- Simple translations, applicable to technical or informational materials such as manuals, studies, or specifications
This distinction matters.
Using the wrong type of translation can lead to delays, requests for correction, or even rejection of the submission.
The real challenge: understanding the dossier
The challenge is not just translating documents, it is understanding:
- The type of document being submitted
- What the regulation requires in each specific case
- How to ensure the entire dossier is coherent and valid in Spanish
In many cases, even technical documents must be available in Spanish when they support regulatory evaluation.
This makes translation a technical decision, not an operational one.
One approach does not fit all industries
The recent Ministry of Health communication (MS-DRPIRS-0960-2026) highlights a key reality: translation requirements are not uniform.
They vary depending on the product category:
- Medical devices
- Pharmaceuticals
- Cosmetics
- Food products
- Chemical products
Each category has specific rules regarding which documents require official or simple translation.
Assuming a single approach applies across all cases is one of the most common risks for companies managing multi-category registrations.
Common mistakes that can delay your submission
Based on our experience in regulated environments, these are some of the most frequent issues:
- Submitting official documents without an official translation
- Providing dossiers partially in English
- Failing to translate elements such as apostilles, seals, or certifications
- Using simple translation where legal validity is required
These issues are not always obvious at the beginning, but they directly impact timelines, costs, and operational continuity.
Translation as part of compliance
In regulated environments, translation is not an additional step, it is part of compliance.
A well-prepared dossier depends not only on its technical content, but on its ability to be properly assessed by the competent authority.
And that is only possible when language is no longer a barrier.
A decision that impacts time, cost, and risk
Properly managing the translation of a regulatory dossier allows you to:
- Reduce approval timelines
- Avoid rework
- Minimize regulatory risk
- Ensure document consistency
In environments where every day counts, these factors make a real difference.
Final thought
Language is not a detail.
It is part of the system that validates your product.
