Paraguay Medical Device Registration 2026: Translation Rules for Foreign Technical Documents

1. Key takeaways

1. Article 7 of the operating instructions: all foreign technical documents must be translated into Spanish by a public translator registered with the Supreme Court (traductor público matriculado).
2. Article 7.1 provides a relief rule: where the manual or technical documentation submitted is voluminous, only the pages containing the technical information used in the platform declaration need to be translated; a full translation is not required.
3. Article 11 governs the signature form: the public translator must sign each page; where the signature appears only at the end of the document, the document must carry page numbers and state the total number of pages covered by that signature.
4. Article 12 requires the source document, the translation and the legalization seal, whether apostille or consular, to be merged into a single file for upload. In practice the per-page signing option costs less than it appears, since most registered translators include it in the certified translation fee, and it removes an entire failure mode from the dossier.

2. Legal basis

The resolution states the underlying requirement that foreign documents be submitted in Spanish, and the operating instructions translate that requirement into four operational rules: who may translate, how much must be translated, how the translation must be signed, and how the file must be assembled before upload to DINAVISAPy. Article 1 of the operating instructions ties the whole file together: the evaluation does not start until the submission is complete, so an incomplete translation does not merely lower quality, it suspends the application. The translation work should therefore be scheduled with the same rigor as the certificates themselves, with the translator engaged early and the page scope frozen before the translator starts. The rules also interact with the legalization step, since the seal must travel with the file it certifies.

3. Expert insights

Insight one: Article 7.1 is an underrated cost provision. Technical manuals for large equipment can run to hundreds of pages, and translating them in full makes both the cost and the schedule uncontrollable. Article 7.1 states expressly that only the pages containing the technical information used in the platform declaration need to be translated, compressing the translation volume from the whole manual down to what the declaration actually relies on. The precondition, however, is that the applicant can identify precisely which pages will be referenced, which requires building the mapping between the platform fields and the manual page numbers before commissioning any translation. Without that mapping, the partial-translation relief cannot be used safely. The mapping table costs a day of work and pays for itself immediately, because it converts an open-ended translation assignment into a bounded instruction that the translator can price and schedule exactly.

Insight two: the signature requirements exist to prevent page substitution. Article 11 requires the translator to sign each page, or, where the signature is placed only at the end, to number the pages and state how many pages the signature covers. This is an anti-tampering design: if only the last page carries a signature, the intermediate pages could be swapped without detection. Companies that follow the domestic habit of stamping only the final page will have their translations rejected, and the rejection will surface late, when the dossier is already in review. The same discipline applies to the Spanish text itself: the translator must be given the official terminology of the resolution, so that the translation reads as a regulatory document rather than a marketing one.

Insight three: the single-file rule is a hard constraint at the upload layer. Article 12 requires the source document, the translation and the legalization seal to be merged into one file. Uploading them separately is treated as an incomplete submission, which triggers the situation described in Article 1, where the evaluation does not start until the file is complete, and the time spent repairing the upload counts against the applicant. Assembly discipline at the scanning stage therefore protects the project schedule as much as it protects compliance. A short pre-upload checklist, run by the person who assembles the PDF, is enough: one file, the correct order of original, translation and seal, and page numbers visible.

4. Practical recommendations

1. Build the mapping table between platform fields and manual page numbers first, and use it to define the translation scope under Article 7.1, and keep the table under version control, since any manual revision shifts the pages the declaration relies on.
2. Agree with the registered public translator on per-page signing, or apply Article 11 by numbering the pages and stating the total covered on the final page, keeping a specimen signed page on file for future submissions.
3. Merge every foreign document, its translation and its legalization seal into a single PDF before upload.
4. Front-load the translation schedule: translation is among the activities most likely to stretch the project timeline (practical estimate: project experience), so order the translation in the first week of the project rather than the last.
5. Keep the final translated pages, the translator registration details and the signed specimens together in the dossier archive, so that any later re-upload can reproduce the original file exactly.
6. Brief the translator on the regulatory context as well, since a translator who understands what the pages are used for asks fewer questions and delivers a cleaner certified text.

5. Verification checklist

• □ Mapping table between platform fields and manual page numbers established
• □ Translation scope defined under Article 7.1, not full-text by default
• □ Translation issued by a public translator registered with the Supreme Court
• □ Translation signed per page, or page-numbered under Article 11
• □ Source document, translation and seal merged into a single file

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and conformity support in Paraguay for medical device manufacturers, importers and authorized representatives, including translation scoping and certified translator coordination. For assistance, contact info@grzanglobal.com.