Paraguay Reliance Framework: Resolución 147/2024 Good Practices and the Annual Official List

1. Key takeaways

1. Resolución DINAVISA N° 147/2024 approved a good practices manual for the use of regulatory decisions of other authorities, whose scope of application expressly includes medical devices and in vitro diagnostic products (together with medicines, vaccines, blood and blood products). The manual is therefore a cross-sector instrument with a dedicated device relevance.
2. Working together with Resolución N° 148/2024 (the annual official list of reference regulatory authorities), the two instruments form a reliance system in which the list determines eligibility and the manual determines the method. Neither answers the other’s question, and both must be consulted for every reliance-based project.
3. The concrete point where reliance lands for medical devices is the Simplified Registration Procedure of Article 8, inc. a of Resolución N° 226/2024, under which only items b, c, d, g and h of Article 6 are evaluated, with the remaining items filed for the record without individual technical review.
4. The policy objectives of the reliance model include improving availability and response speed, particularly in situations of public health emergency and in the handling of new technologies and new practices, which is why the framework favors products with existing approvals from recognized authorities.

2. Legal basis

Three instruments must be read as one system. Resolución N° 147/2024 supplies the methodological layer, explaining how a regulatory decision of another authority may be used and with what caution. Resolución N° 148/2024 and its updates supply the institutional layer, identifying the authorities whose decisions are eligible for reliance. Article 8 inc. a of Resolución N° 226/2024 supplies the operational layer, converting recognition into a narrowed review scope for imported Class II to IV devices. A reliance project that cites any single layer in isolation is incomplete.

The breadth of the manual’s scope matters for diversified portfolios. Because its application covers medicines, vaccines, blood and blood products, as well as medical devices and in vitro diagnostic products, the same methodological standards govern reliance across a company’s entire Paraguayan submission set, and lessons learned on one product line transfer to the others. For device manufacturers, the practical entry point remains the simplified registration procedure of Article 8 inc. a, which limits the technical evaluation to items b, c, d, g and h of Article 6 while the full file stays on record. The combined effect is that eligibility is checked against the current list, the method is checked against the manual, and the file is checked against the resolution, in that order.

3. Expert insights

Insight one: reliance in Paraguay is institutionalized, not a matter of case-by-case discretion. The list (148/2024) answers the question of whom to rely on; the manual (147/2024) answers the question of how to apply reliance. With both instruments in written form, the predictability of the simplified procedure improves markedly: companies can assess their own eligibility in advance instead of waiting for an individual regulatory response for each case. This predictability is itself a planning asset, because submission sequencing, budgets and launch dates can be committed before the file ever reaches DINAVISA.

Insight two: reliance does not mean automatic approval; the boundary conditions are written into the operative text. Article 8 inc. a retains two constraints: first, all requirements of Article 6 must still be submitted, so the file remains complete; second, the conditions of the product must not deviate from those approved in the original approval country. The manual standardizes the method but does not remove the substantive judgment. A foreign approval is the entry ticket to the simplified pathway, not a substitute for the Paraguayan file, and the reviewer retains the power to reject a product whose approved conditions have drifted from what the foreign authority actually endorsed.

Insight three: the reliance model and regional cooperation reinforce each other. On August 20, 2026, DINAVISA and the Brazilian agency ANVISA signed a new memorandum of understanding on cooperation, replacing the earlier memorandum of March 2024, with a validity of 5 years, covering product categories including medical devices and providing for laboratory data sharing, inspection coordination and the exchange of post-market surveillance information. For products already approved in Brazil, the practical value of this channel will continue to rise as the cooperation mechanisms mature, and regional approvals increasingly function as the fastest gateway into Paraguay.

4. Practical recommendations

1. Before project initiation, verify both elements: the current-year list (eligibility) and the manual (method). Both are indispensable, and neither alone is sufficient to support a reliance-based submission.
2. In preparing the dossier under the reliance pathway, focus on the accuracy and mutual consistency of the five items b, c, d, g and h of Article 6, since these are the items the reviewer will actually evaluate.
3. For products already approved by regional reference agencies such as ANVISA and ANMAT, prioritize them in the Paraguayan submission sequence to capture the cooperation dividend before competitors with equivalent files.
4. Retain written evidence supporting every reliance conclusion, including the version of the list and the text of the agreement, so that the basis can be explained during later inspections or renewals without relying on institutional memory.

5. Verification checklist

• □ Manual of Resolución N° 147/2024 obtained and the device scope of application checked
• □ Version of the current-year official list verified and recorded in the project file
• □ Consistency of the five items b, c, d, g and h locked down for the reliance dossier
• □ Written evidence of the list version and the agreement text retained for inspections and renewals
• □ Cooperation value of ANVISA and ANMAT approvals assessed in the submission sequence

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support for manufacturers, importers and authorized representatives in Paraguay, covering reliance strategy, reference eligibility assessment and dossier preparation under Resoluciones N° 147/2024 and N° 148/2024. Contact: info@grzanglobal.com