Paraguay Medical Device Regulation 2026: MERCOSUR GMC Resolutions and Transposition Status

1. Key takeaways

1. Under its Dispositivos Médicos y Odontológicos (DM) section, the DINAVISA website still publishes three MERCOSUR resolutions: GMC N° 50/1998 (single-use sterile hypodermic syringes), GMC N° 72/1998 (the MERCOSUR technical regulation on essential safety and efficacy requirements for medical devices) and GMC N° 75/2000 (natural rubber condoms for men), so the regional layer of Paraguayan device law is visible on the national regulator page itself.
2. GMC N° 72/98 retains current technical effect: the official operating instructions expressly require that, when Class III and Class IV devices declare the description of efficacy and safety, that resolution and its updates must be taken into account, which makes the 1998 regulation a live drafting input for every high-class dossier filed today.
3. The new-generation regional registration technical regulation GMC N° 25/21 (adopted in Montevideo on October 13, 2021) has completed domestic transposition in some member states, for example Argentina, which incorporated it in January 2025 through ANMAT Provision 64/2025, simultaneously replacing GMC 40/00; the progress of transposition in Paraguay must be confirmed against official DINAVISA publications, not inferred from what neighboring members have done.
4. Until Paraguay completes the transposition, the classification rules and dossier requirements for device registration continue to follow Resolución N° 226/2024 and its Annex I, and regional developments should be tracked as intelligence, not applied as law.

2. Legal basis

3. Expert insights

Insight 1: GMC 72/98 states essential requirements, not a document checklist. It sets the safety and efficacy outcomes that devices must satisfy, not a submission format. Precisely for that reason it can coexist indefinitely with Resolución N° 226/2024, which governs procedure and dossier content while 72/98 governs technical substance. The instruction that Class III and Class IV filings must take 72/98 into account is, in substance, a requirement to organize the efficacy and safety argumentation within the framework of the essential requirements, and reviewers can test the narrative against that structure. Manufacturers should keep the 72/98 requirements table in the master file so every Class III and IV narrative can be mapped against it without re-reading the regulation each time. That mapping also shows gaps early, while there is still time to generate the missing evidence.

Insight 2: regional transposition is in progress, so planning must not assume it is done. The entry into force of GMC 25/21 depends on each member state completing its domestic incorporation; Argentina has already done so, while no transposition by Paraguay appears in official publications. Inferring from the Argentine transposition that Paraguay will follow soon, and preparing dossiers on that assumption, mistakes a regional instrument for a national one. The only reliable basis for judging the status is the DINAVISA website and the official gazette, and planning documents should record the verification date each time the assumption is revisited. Where a program spans several member states, the divergence should be recorded per country in the regulatory plan, with a national versus regional applicability table rather than one shared regional assumption.

Insight 3: certain product categories have their own technical regulations, so the general rules are not the whole story. Syringes and condoms are covered by dedicated MERCOSUR technical regulations (GMC 50/98 and GMC 75/2000). When such products are registered in Paraguay, the indicator requirements of the dedicated technical regulation must be checked in addition to the general requirements. This layer is easy to miss because it sits outside the national resolution, and a dossier that ignores it may pass admission but fail technical review. The check belongs in the dossier preparation checklist, not in the reviewer’s memory, so it survives staff changes. For the covered categories, the dedicated indicators should also be reflected in the technical file index so reviewers can find them without searching the whole dossier.

4. Practical recommendations

1. Organize the summary of efficacy and safety for Class III and Class IV devices according to the framework of the essential safety and efficacy requirements of GMC 72/98, and attach supporting documents such as clinical evaluations issued by the manufacturer, so the narrative and the evidence follow the same structure the reviewer expects.
2. Maintain a tracking ledger of MERCOSUR resolutions and compare, every quarter, whether the published list in the DM section of the DINAVISA website has been updated, recording the date of each check in the ledger itself.
3. For categories with dedicated technical regulations, such as syringes and condoms, maintain a separate indicator verification sheet covering each relevant requirement, and route the sheet through the same review chain as the general dossier.
4. For any claim that Paraguay has adopted GMC 25/21, require the claimant to produce an official DINAVISA source; absent such a source, treat the regulation as not transposed, and reflect that treatment in project plans, templates and client advice until an official publication says otherwise. Each quarterly check should record not only the date but also the exact page consulted, so the basis of the conclusion is reproducible.

5. Verification checklist

• □ Efficacy and safety summaries for Classes III and IV organized according to the GMC 72/98 framework
• □ Tracking ledger of MERCOSUR resolutions established
• □ Dedicated technical regulation indicators checked for categories such as syringes and condoms
• □ Transposition status of GMC 25/21 in Paraguay confirmed against an official source (absent official publication, treated as not transposed)
• □ Classification and dossier requirements still follow Resolución N° 226/2024

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.