Paraguay Simplified Registration Procedure: Reference Authorities under Resolución 148/2024

1. Key takeaways

1. Article 8, inc. a establishes the Simplified Registration Procedure (Proceso simplificado de Registro Sanitario), applicable to imported Class II, III and IV devices. It is the principal fast lane within the Paraguayan framework for products with an existing foreign approval.
2. The condition for eligibility is that the product has been approved by a regulatory authority included in the Annual Official List (Listado Anual Oficial) contained in Resolución DINAVISA N° 148/2024 or its updated versions, or has been approved by a regulatory authority with which Paraguay has concluded a bilateral recognition agreement that has been published on the DINAVISA website.
3. Simplified does not mean fewer submissions: the applicant must still submit all requirements of Article 6. What changes is that DINAVISA performs the technical evaluation only on items b, c, d, g and h, namely the agency authorization, the outsourcing contract, the free sale certificate, the Spanish-language labeling and instructions for use, and the radiation permit.
4. A hard precondition applies: the conditions of the product must not deviate from those approved by the regulatory authority of the original approval country. Any change in the indications, labeling, structure or any other element removes the eligibility for the simplified pathway and pushes the product into the integral analysis.

2. Legal basis

The three instruments operate on different layers. Resolución N° 148/2024 and its updates identify which foreign regulatory authorities are accepted as references; Article 8 inc. a of Resolución N° 226/2024 converts that recognition into a shortened review scope; and the operational instructions, at page 9, describe the process flow an importer follows in practice. Eligibility is therefore a compound judgment that touches all three layers at once: the authority must be listed or covered by a published bilateral agreement, the product must hold the foreign approval, and the product as presented in Paraguay must match what the foreign authority approved, element by element, from the indications to the label.

3. Expert insights

Insight one: what is simplified is the depth of review, not the documentary obligation. The wording of Article 8 inc. a is that the applicant must submit all requirements prescribed in Article 6, and only then is the scope of the evaluation limited. This design preserves a complete file on record at DINAVISA while concentrating review resources on the qualification of the parties (b, c) and the origin and presentation of the product (d, g, h). What these five items share is that they determine who answers for the product, whether the product is lawfully on the market in its origin jurisdiction, and what the user actually sees on the label and in the instructions for use.

Insight two: the no-deviation condition is a dynamic constraint, not a one-time judgment at the moment of submission. If the content approved in the original approval country changes while the Paraguayan evaluation is under way, for example through an indication expansion or a labeling redesign, the simplified eligibility may be lost. The practical estimate, derived from the literal text of the provision, is that changes in the country of origin should be frozen after submission, and remain frozen until the Paraguayan certificate is issued. Coordinating this freeze across a global regulatory affairs function is the main operational challenge of the simplified route.

Insight three: the list is updated annually, so eligibility must be re-verified every year. Article 8 inc. a refers to the Annual Official List and its updates. When DINAVISA publishes a new annual list, the previous list is superseded, and the effect of the new list continues until the next update. Any project justified by the assumption that the authority was on the list last year carries a real risk of deviation; the current-year list is the only valid reference, and the same is true for products already on the market, whose renewal planning must also track list changes.

4. Practical recommendations

1. At the project initiation stage, first make the reference eligibility determination: verify whether the original approval authority of the product is on the current-year list, or whether a published bilateral recognition agreement exists, and record the version of the list relied upon for later audits.
2. Under the simplified pathway, still prepare the complete dossier under Article 6; do not remove other documents merely because only five items are evaluated, since the file must be complete for the record even where the review is scoped down, and an incomplete file can still be sent back at intake.
3. After submission, freeze product changes in the country of origin, including indications, labeling and structure, until the Paraguayan certificate is issued, and coordinate the freeze with the teams controlling the reference market.
4. Review the list updates every year, and re-assess the simplified eligibility of products under review and already on the market whenever the list is refreshed, feeding the result directly into renewal planning.

5. Verification checklist

• □ Current-year official list verified (Res. 148/2024 and its updates), with the list version recorded
• □ Existence of a published bilateral recognition agreement confirmed on the DINAVISA website
• □ Article 6 dossier submitted in full (no reduction on account of the simplified procedure)
• □ Product conditions confirmed identical to the content approved in the original approval country, with the origin changes frozen during the review
• □ Annual list review mechanism established, covering both pipeline and marketed products

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support for manufacturers, importers and authorized representatives in Paraguay, covering reference eligibility assessment, dossier preparation and annual list monitoring under the simplified registration procedure. Contact: info@grzanglobal.com