Paraguay NSO Application: Sworn Declaration (Declaración Jurada) and Article 6 Dossier Requirements

1. Key takeaways

1. For a Class I device to be registered through the NSO, the application must simultaneously satisfy three elements: the declaration of rules and classification signed by the technical director (Article 4), the sworn declaration (declaración bajo fe de juramento) of Class I status made in accordance with Annex II, and compliance with all requirements of Article 6. Omitting any one of these three elements prevents the application from proceeding, and the three are checked together at intake rather than sequentially.
2. Once issued, the NSO serves as the basis for the automatic authorization to manufacture or import Class I devices, covering both domestically produced and imported products, as established by Article 7. No additional import permit is layered on top of it for each consignment.
3. Article 28 provides that the contents of Annexes I, II, III and IV all have the nature of sworn declarations, with all information being the responsibility of the applicant; where falsification, forgery or alteration is established, the applicant bears civil, criminal and administrative liability.
4. The official operational instructions add a further requirement: all uploaded documents must carry the digital signature of the technical director (Regente), and the signature must appear in a prominent position on the first page without obscuring any data in the document.

2. Legal basis

Read together, the two instruments draw a clear line between substance and form. Resolución DINAVISA N° 226/2024 supplies the substantive requirements: what must be declared, who signs, which annex applies and what liability attaches to false statements, including the reference in Article 31 to Article 243 of the Paraguayan Criminal Code. Instructivo ITR–DGRS-002, Versión 02 supplies the formal layer: how files are uploaded, how signatures are affixed, how scanned originals are authenticated, and how the NSO process flow runs on page 7 of the guide.

A submission is complete only when both layers are satisfied at the same time, and the NSO process flow on page 7 of the guide reflects that simultaneity by listing the declaration, the signature and the dossier items at the same intake stage.

3. Expert insights

Insight one: the sworn declaration system trades upfront review cost for post-market liability. The regulator does not review each item, but Article 28 anchors the responsibility on the applicant personally, and Article 31 further invokes Article 243 of the Paraguayan Criminal Code, so a false statement is not a mere administrative slip. The practical effect of this design is that the greatest risk for a Class I project lies not in the review itself but in sustained consistency after the document is obtained: if the actual product parameters, labeling or intended use diverge from the declaration, the conduct constitutes a false declaration rather than a simple regulatory infraction, and the consequences escalate across civil, criminal and administrative dimensions rather than being limited to a corrective order.

Insight two: the digital signature is a formal requirement, not a technical detail. Section 2 of the operational instructions requires that all uploaded documents bear the digital signature of the technical director, and Section 2.1 further requires that scanned copies of original documents be previously authenticated by a notary office. Failure on this point blocks the submission directly within the system: where formal requirements are not met, the technical evaluation will not even begin, and the file returns to the applicant without substantive progress. Because every document in the package must carry the signature, a single unsigned annex stalls the entire application, which is why signature completeness deserves its own pre-submission check.

Insight three: the sworn declaration and the Article 6 dossier are cumulative, not alternative. A common misconception is that a Class I product relies on the declaration alone and therefore needs no technical file. Article 7 states expressly that the NSO application must satisfy the requirements of Article 6 and that the technical information must be declared on the platform with documents uploaded. The declaration covers the classification judgment; the dossier covers the product itself. Both layers must be complete and mutually consistent, because a mismatch between what is declared and what the dossier shows is itself a finding against the applicant.

4. Practical recommendations

1. Prepare the full dossier for Class I products under Article 6 as well, and keep the declaration documents and the technical dossier as separately organized records, so that each layer can be produced and inspected independently during an audit.
2. Maintain a register of the technical director’s digital signature and verify document by document that the signature position does not obscure any data, checking first pages in particular since that is where the instructions require the signature to be prominent.
3. After the NSO is issued, verify annually that the fields declared on the platform remain consistent with the actual product, and retain the verification records as evidence of ongoing conformity; annual verification also surfaces drift early, while it can still be corrected through the ordinary change route of Article 13.
4. Archive all supporting documents issued by the manufacturer, including instructions for use, technical documentation, catalogs and clarification letters, as the underlying evidence supporting the declaration; these are the materials that transform a sworn statement into a defensible position.

5. Verification checklist

• □ Annex II sworn declaration template obtained and correctly completed
• □ Article 6 dossier fully prepared (equally applicable to Class I) and filed separately from the declaration
• □ All uploaded documents bearing the digital signature of the technical director, prominent on the first page and not obscuring data
• □ Scanned copies authenticated by a notary office before upload
• □ Annual post-issuance consistency verification mechanism established, with records retained

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support for manufacturers, importers and authorized representatives in Paraguay, covering sworn declaration drafting, Article 6 dossier preparation, digital signature compliance and post-issuance consistency management. Contact: info@grzanglobal.com