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22 Jul

[Blog] Paraguay Launches National Traceability System for Medicines and Medical Devices

by Milena Atanasova
in Blog, news
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Paraguay Launches National Traceability System for Medicines and Medical Devices

 

In April 2025, Paraguay took a significant step toward pharmaceutical supply chain modernization by launching the National System for the Traceability of Medicines and Medical Devices through Decree № 3668/25. This new regulation sets the foundation for a mandatory traceability framework, ensuring that every medicine and medical device in the country can be uniquely identified, tracked, and authenticated.

The system aims to enhance patient safety, prevent falsified or illegal products, and digitize public health infrastructure.

 

Key Objectives of the New Traceability System

 

The Paraguayan traceability model will introduce:

 

  • A unified national coding standard
  • Full traceability across manufacturing, importation, and distribution
  • Real-time tracking and verification capabilities
  • A central product catalogue called the “National Dictionary of Medicines and Related Products”
  • Seamless data exchange between public institutions and private sector partners

These updates align with global traceability best practices and position Paraguay for enhanced interoperability with other regulated markets.

 

 

Who Is Affected?

 

All players in the pharmaceutical and medical device supply chain operating in Paraguay must prepare for compliance. This includes:

 

  • Local and international manufacturers
  • Importers and distributors
  • Public and private pharmacies
  • Government procurement institutions
  • Healthcare providers

 

 

Companies will be required to register their products, apply standardized codes, and report traceability events to the national platform once it becomes operational.

 

 

 

Timeline and Implementation Plan

 

According to Decree № 3668/25:

 

  • The Ministry of Public Health and Social Welfare must draft and submit a National Action Plan within 30 days of the decree.
  • The system will be developed jointly with DINAVISA (National Directorate of Health Surveillance) and MITIC (Ministry of Information and Communication Technologies).
  • A digital traceability platform will be deployed to ensure data collection, reporting, and verification of medicines and devices throughout the supply chain.

 

 

DINAVISA has committed to publishing the first official product codes and integration guidance in the near future.

 

 

 

Why It Matters for Compliance and Supply Chain Efficiency

 

This regulatory development is more than just a legal obligation. It introduces:
  • Protection against falsified medicines through secure, serialized identification
  • Improved inventory control and product recalls
  • Stronger public trust in the pharmaceutical system
  • A major step forward in Paraguay’s digital health transformation
For companies already active in serialized markets such as the EU, Brazil, or Saudi Arabia, Paraguay’s model aligns with common GS1 and global traceability standards.

 

 

 

SoftGroup’s Expertise in Supporting Regulatory Traceability

 

 

At SoftGroup, we support pharmaceutical companies and regulatory authorities in implementing end-to-end serialization and traceability systems. Our solutions are designed to adapt to evolving local requirements like those in Paraguay—whether you’re preparing for initial onboarding or integrating your ERP and master data systems.
We can guide manufacturers, importers, and distributors through:
  • National compliance readiness
  • Serialization software implementation
  • Aggregation and partner data exchange
  • Reporting to national hubs
Official Sources:

 

 

Need to Ensure Compliance in Paraguay or Other LATAM Markets?

 

 

 

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