Paraguay Medical Device Traceability: Decree 3668/2025 and the National Traceability System

1. Key takeaways

1. Decreto N° 3668/2025 (issued by the executive branch on April 8, 2025) establishes the National Traceability System for Medicines and Medical Devices (Sistema Nacional de Trazabilidad de Medicamentos y Dispositivos Médicos), also referred to as the National Medicines Catalog (Catálogo Nacional de Medicamentos).
2. System objectives: achieve unique identification of medicines and medical devices, promote traceability and transparency across the distribution chain, optimize the healthcare supply chain, and protect patient safety.
3. The core component is the National Dictionary of Medicines and Related Products (Diccionario Nacional), a unified database that assigns a unique code to every medicine and medical device.
4. Division of responsibilities: DINAVISA compiles, approves and updates the nomenclature and codes in the catalog, benchmarked against international standards; the Ministry of Economy and Finance and the National Directorate of Public Procurement use it as a mandatory reference for procurement involving coded medical supplies; MITIC builds the interoperability platform; MSPBS drafts and executes the national action plan, to be submitted within 30 days.

The dictionary approach mirrors well-known international models in which a single coded catalog feeds registration, procurement and vigilance alike. Paraguay is therefore not inventing a mechanism but localizing one, and experience from neighboring systems suggests that coding discipline pays off long before enforcement begins.

2. Legal basis

The decree does not stand alone. Article 23 of Resolution 226/2024 adopts the UMDNS generic nomenclature and Article 22 defines the DMNSO code structure for registered devices, so the vocabulary of the national catalog is already anchored in the registration framework. Companies that submitted accurate UMDNS and naming data at registration have, in effect, been pre-formating the inputs that the traceability system will consume, which is why registration data quality now has consequences well beyond the registration file itself.

The institutional design of the decree distributes one logical process across five bodies: DINAVISA owns the dictionary and its codes, the economic and procurement authorities consume them for purchasing, MITIC supplies the technical platform, and MSPBS drives the health-system action plan on a 30-day submission clock. The 30-day clock signals that the health authorities were expected to move quickly after publication, which is consistent with the pace observed across the wider 2024–2026 regulatory generation. For a manufacturer, the practical consequence is that a single data point, the catalog code of a product, simultaneously touches registration, procurement and health-system planning, so its accuracy pays dividends in three directions at once.

3. Expert insights

Insight one: the traceability system and the naming rules of Resolution 226/2024 are two ends of the same governance logic. Article 23 of the Resolution, with its UMDNS generic nomenclature, and Article 22, with the DMNSO code structure, solve identification at the registration end; the national catalog of Decreto 3668/2025 solves identification at the distribution and procurement end. Both depend on a unified naming discipline, which shows that Paraguay is extending its identification system from the registry into the supply chain. For manufacturers, this means the naming decisions taken during registration will follow the product for its entire market life.

Insight two: the mandatory linkage with public procurement gives the catalog codes commercial force. The Ministry of Economy and Finance and the National Directorate of Public Procurement must treat the catalog as a mandatory reference for procurement involving coded medical supplies. For product lines that depend on the public channel, including MSPBS and IPS facilities, not obtaining a catalog code is in substance equivalent to losing bidding eligibility. That is a heavier commercial consequence than a pure traceability obligation would be, and it moves catalog compliance from the regulatory affairs agenda onto the commercial agenda.

Insight three: because DINAVISA compiles the catalog, coding work will migrate upstream into the registration process. The catalog is compiled, approved and updated by DINAVISA, which means the naming and coding data provided in submissions are likely to feed the catalog directly. The accuracy of platform fields therefore acquires a much longer shadow (practical estimate: an inference based on the division of duties). A generic name or code entered carelessly at registration may surface years later as a procurement mismatch that is far more expensive to fix than the original typing effort would have been.

4. Practical recommendations

1. Raise the priority of accurate UMDNS codes and generic names in submissions to the level of a procurement-eligibility issue, and review them before every filing rather than treating them as free-text fields.
2. Track the official DINAVISA releases on the technical parameters and implementation phases of the national catalog, in particular whether a separate implementation timetable is set for medical devices as distinct from medicines.
3. For product lines dependent on the public channel, confirm with local partners in advance how catalog codes will be obtained, and record the process owner on each side.
4. Include the traceability requirements in agreements with the certificate holder, making the responsibility for data submission and for keeping coded information current explicit and enforceable.

Interoperability is the quiet engine of the system. Once the MITIC platform connects the catalog to procurement and health information systems, code errors stop being administrative dust and become transaction blockers: an invoice, a tender or a delivery that cannot be matched to a catalog code stalls. Early code hygiene is therefore cheaper than later remediation in a live procurement environment.

5. Verification checklist

• □ It is confirmed that Decreto N° 3668/2025 covers medical devices in its scope
• □ The accuracy of submitted UMDNS codes and generic names has been reviewed
• □ Official releases on catalog technical parameters and implementation phases are being tracked
• □ The code acquisition process for public-channel product lines has been confirmed (practical estimate)
• □ Agreements allocate the responsibility for traceability data submission

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and post-market compliance support for medical device manufacturers, importers and authorized representatives in Paraguay. For assistance with traceability readiness, coding strategy or any other regulatory matter, contact info@grzanglobal.com.