Paraguay Medical Device Market Entry: NSO vs Registro Sanitario under DINAVISA Resolution 226/2024

1. Key takeaways

1. Paraguay permits only two pathways to place a medical device on the market: Class I (Clase I) devices proceed through the mandatory sanitary notification, the NSO (Notificación Sanitaria Obligatoria), while Class II, III and IV devices must obtain the Sanitary Registration Certificate (Certificado de Registro Sanitario). Selecting the correct pathway is therefore the first and most consequential regulatory decision for any manufacturer or importer entering Paraguay, and it shapes everything that follows, from dossier design to customs clearance.
2. Article 7 establishes that the NSO is a registration and market authorization document issued by DINAVISA on the basis of the applicant’s sworn declaration. With this document in hand, the holder is automatically authorized to manufacture or import Class I devices, whether domestically produced or imported.
3. For imported Class II, III and IV devices, the registration route splits into two further sub-pathways after acceptance of the application: the Simplified Registration Procedure (Article 8, inc. a) and the Integral Analysis (Article 8, inc. b). The applicable sub-pathway depends on whether the product already holds an approval from a reference regulatory authority recognized by Paraguay.
4. Both types of documents carry the same validity period of 10 years, renewable for successive periods of equal length under Article 10. Because the validity and renewal logic is shared, renewal planning can be built into a single compliance calendar regardless of the pathway chosen, and lapse of the document means lapse of the authorization to trade.

2. Legal basis

Resolución DINAVISA N° 226/2024 is the consolidated instrument governing market authorization for medical devices in Paraguay, covering the classification of pathways, the content of applications, post-market changes and renewals. It entered into force on 2024-09-16 through the effect given by its Article 36. The companion document, Instructivo ITR–DGRS-002, Versión 02, dated 2024-09-09, translates the resolution into operational process flows, dedicating separate pages to the NSO, to domestic products, to imported products and to the integral analysis, and it is the reference that reviewers apply when checking the formal completeness of a submission.

3. Expert insights

Insight one: the difference between the two pathways is not one of strictness but of where responsibility is placed. The NSO is a registration of a sworn declaration: DINAVISA does not carry out a point-by-point technical review, and the center of gravity of responsibility rests squarely on the applicant. The registration certificate, by contrast, is the conclusion of an approval process, and responsibility is distributed across the review stage. Understanding Class I as a simplified version of Class II is a mistake: it follows a different logic altogether, one built on self-declaration backed by personal liability. The documentary system is also separated: Annex II is used for the Class I sworn declaration, Annex III for declarations after changes, and Annex IV for renewal declarations, so each lifecycle event carries its own declaration instrument.

Insight two: the automatic import effect of the NSO is its core commercial value. Article 7 states expressly that the NSO is valid for the purpose of automatic manufacture or import. This means that once a Class I device holds an NSO, consignments can clear customs without a separate import license being requested for each batch. For low-value, high-turnover consumable product lines, this is a decisive lever for shortening time to market and reducing the per-shipment administrative burden. The saving compounds over a 10-year validity period: hundreds of shipments may cross the border on the strength of a single notification document, provided the customs paperwork mirrors the certificate exactly.

Insight three: the choice of pathway also determines the cost structure of subsequent changes. The NSO is subject to the change classification of Article 13, but an incorrect category judgment triggers the three consequences of Article 7. The pathway decision is therefore not a matter of trying the cheaper option first; it is a determination that must be completed and documented before submission, because once the NSO is issued there is no channel to correct the declared class, and the only exit from a wrong classification is invalidity and withdrawal.

4. Practical recommendations

1. Build a pathway mapping table for every product line before any submission is drafted: Class I devices map to the NSO, Class II to IV devices map to the registration certificate; for imported products, additionally determine whether the simplified registration procedure applies, since that determination changes the review scope and the project plan.
2. Have the sworn declaration for Class I products signed by the technical director (Regente) and retain the classification rationale working file, including the rule-by-rule reasoning, so the file can withstand later inspections without reconstruction.
3. Before submitting Class II to IV projects, confirm whether the product already holds an approval from a reference regulatory authority, in order to pursue the simplified procedure and shorten the review (see article 14 of this series for the conditions and limits of that route).
4. In the import clearance process, Class I devices clear customs on the NSO and Class II to IV devices on the registration certificate; keep customs documentation and certificate numbers perfectly consistent, since a mismatch between the declaration papers and the certificate can hold a shipment at the border even though the underlying authorization is valid.

5. Verification checklist

• □ Pathway mapping (NSO or registration certificate) completed for every SKU, documented and signed off
• □ Class I sworn declaration signed by the technical director with the classification rationale on file
• □ Simplified registration procedure eligibility assessed for imported Class II to IV devices
• □ Certificate numbers in customs documentation consistent with the certificate, verified per shipment
• □ The 10-year validity period incorporated into the renewal schedule, with the renewal declaration under Annex IV planned ahead of expiry

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support for manufacturers, importers and authorized representatives in Paraguay, covering pathway determination, dossier preparation, customs alignment and renewal management under Resolución DINAVISA N° 226/2024. Contact: info@grzanglobal.com