Paraguay Medical Device Regulation 2026: Repeal of Resolution 669/2016 and Transition

1. Key takeaways

1. Resolución S.G. N° 669/2016 (October 19, 2016, issued under Article 4, inc. b) of Ley N° 4659/12) was repealed in its entirety (abrogada) by Resolución S.G. N° 554/2024 (Asunción, September 16, 2024). No part of the 2016 rules survives as current law, and no saving clause carries its document list into the new regime.
2. The trigger for the repeal was a request for repeal submitted by DINAVISA through Memorandum No. 1533 (Nota DINAVISA N° 1533) issued on September 12, 2024, four days before the instrument was signed, which shows how tightly the repeal was coordinated with the entry into force of the replacement regulation.
3. The only instruments now in force are Resolución N° 226/2024 plus the operating instructions Instructivo ITR–DGRS-002, Version 02; Article 34 simultaneously provides that certificates already issued remain valid until expiry, with renewals converted to the new rules, so holders face no forced migration of live certificates.
4. The most common error in practice is that lists of requirements from the 2016 version still circulate online, and dossiers are assembled item by item from those lists, so that the classification basis, the document items and the submission fields all drift out of alignment (practical estimate: industry observation). The drift is invisible until the file is reviewed, which is precisely when it is most expensive to fix.

2. Legal basis

3. Expert insights

Insight 1: the repeal date and the entry-into-force date fall on the same day, which is a deliberate seamless transition. The signing date of Resolution 554/2024 (September 16, 2024) and the effective date of Resolution 226/2024 (September 16, 2024) are identical, avoiding any regulatory vacuum. The same-day coordination also signals that the authority prepared the replacement before publishing the repeal, which is why both texts can be read together as one package. This suggests a simple dating test for judging the vintage of any dossier: a checklist that cites only Resolution 669/2016 and never cites Resolution 226/2024 is necessarily a product of the period before September 16, 2024, and its contents should be presumed outdated until verified line by line against the current regulation. The test costs nothing and catches the single most common obsolete-dossier pattern in this market.

Insight 2: the treatment of existing certificates under the repeal is gentle. Article 34 adopts a transition arrangement of grandfathered validity until expiry plus conversion to the new rules at renewal, which shows that DINAVISA chose the path of minimizing market disruption. For companies this means that existing certificates require no urgent action, but renewal preparation must start early under the new rules, because the renewal window is only 120 business days before expiry. A renewal dossier built on the 2016 structure will consume much of that window just being corrected. That preparation period should include a mock review against the Article 12 checklist, so deficiencies are found by the company and not by the reviewer. For products close to expiry, the countdown table should trigger the impact assessment immediately rather than waiting for the routine planning cycle.

Insight 3: the real residual risk sits in third-party documents. Distribution agreements, quality agreements and power of attorney templates frequently contain clauses requiring compliance with Resolution No. 669/2016 and its annexes. After the repeal, such clauses point to an instrument that no longer exists, and in a dispute they become unenforceable. These commercial documents are reviewed far less often than registration dossiers, which makes them the layer where obsolete references survive the longest, so they deserve a dedicated sweep rather than incidental correction. A clause that names a repealed instrument can also complicate insurance, tender and audit reviews, where counterparties verify cited law before signing. The sweep should include templates stored in shared drives, not only executed agreements, because unused templates become tomorrow’s signed contracts.

4. Practical recommendations

1. Run an immediate keyword search across all Paraguay-related documents for 669 and 2016, and for every hit, revise the reference to Resolución N° 226/2024 together with the corresponding article number, keeping a change log of each corrected document so the sweep can be audited later.
2. Build an expiry date countdown table for existing certificates: 120 business days before expiry is the deadline for filing the renewal, and a preparation period of 3 to 6 months should be reserved before that point for gap analysis, supplementary testing and internal approvals.
3. Require every Paraguay registration checklist supplied by distributors to state its source and date; where no source is given, verify every item against the official PDF before use, and discard unverifiable lists rather than patching them.
4. In internal training, make the sequence repealed by 554/2024, in force is 226/2024 the first lesson of every Paraguay project briefing, so the correct baseline reaches every function involved in submissions, from regulatory affairs to commercial and logistics teams that assemble shipment document packs. A short written briefing note circulated to all functions costs less than one rejected or delayed shipment caused by an obsolete list.

5. Verification checklist

• □ All documents purged of statements presenting 669/2016 as a current instrument
• □ Distribution agreement and power of attorney clauses updated to point to Resolution 226/2024
• □ Expiry countdown table established for existing certificates, including the 120 business day milestone
• □ Named owner assigned for every existing certificate renewal
• □ Every dossier checklist annotated with official source and date
• □ Confirmed that the Article 34 transition arrangement applies to existing certificates
• □ Keyword sweep results logged with correction dates

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Paraguay for manufacturers, importers and authorized representatives. For inquiries, contact info@grzanglobal.com.