By virtue of Decree No. 3668/25, the Executive Branch of Paraguay has officially established the National System for the Traceability of Medicines and Medical Devices, aiming to create a regulatory, technical, and operational framework that enables more efficient, traceable, and interoperable healthcare management across the country.

The newly established System seeks to ensure the unique identification of medicines and medical devices, promote traceability and transparency throughout their circulation, optimize the healthcare supply chain, and protect patient safety. This will be achieved through the implementation of a universal coding model and an interoperable system architecture among public health institutions.

A core component of the System is the National Dictionary of Medicines and Related Products, a unified database assigning unique codes to each medicine and medical device in Paraguay. This instrument will play a strategic role in both regulatory oversight and public procurement processes, fostering greater transparency and operational efficiency.

Institutional Responsibilities

• The National Directorate of Health Surveillance (DINAVISA) is designated as the authority responsible for compiling, approving, and updating the nomenclatures and codes within the Dictionary, in alignment with international standards.
• The Ministry of Economy and Finance, along with the National Directorate of Public Procurement, will adopt the Dictionary as a mandatory reference for all procurement processes involving coded healthcare goods.
• The Ministry of Information and Communication Technologies (MITIC) will oversee the development of the necessary interoperable platforms and technical solutions for implementation.
• The Ministry of Public Health and Social Welfare (MSPBS) will be responsible for drafting and executing the National Action Plan, which must be submitted within 30 days for review and approval, detailing technical parameters, implementation phases, and interoperability mechanisms.

Mandatory Inter-Institutional Collaboration

The Decree establishes a binding obligation for all State bodies—including decentralized entities, public companies, and binational entities—to cooperate in the progressive implementation of the System. The Action Plan will be governed by principles of urgency, optimization, and transparency.

At ClarkeModet, we can advise on strategy and regulatory filing in all LATAM and EU countries. Contact us at infomarketing@clarkemodet.com for more information. And for legal inquiries or advisory services regarding the implementation of this new regulatory framework, please contact to:
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