Paraguay has an organized product compliance system emphasizing technical regulation, public health, and telecom oversight, with enforcement driven by mandatory national standards, pre-market registration, and import control. Paraguay adopts Mercosur regional standards and aligns with international frameworks such as ISO, Codex, and IEC.

Key Authorities:

• Instituto Nacional de Tecnología, Normalización y Metrología (INTN) – Develops and enforces Paraguayan Technical Standards (NP) and coordinates conformity assessment.

• Dirección Nacional de Vigilancia Sanitaria (DNVS) – Regulates pharmaceuticals, medical devices, food supplements, and cosmetics, including product registration.

• Comisión Nacional de Telecomunicaciones (CONATEL) – Manages telecom and RF device type approval, licensing, and spectrum allocation.

• Dirección Nacional de Aduanas (DNA) – Ensures import compliance and documentation verification at entry points.

Key Compliance Elements:

• Standards and Certification (INTN):

  • INTN enforces compulsory technical standards for:

    • Electrical and electronic products

    • Processed food and beverages

    • Building materials

  • Products may require:

    • Certificate of Conformity (CoC) from a recognized body

    • Testing in INTN-accredited laboratories or through regional equivalency (Mercosur)

• Product Registration (DNVS):

  • Mandatory for:

    • Medicines and vaccines

    • Medical devices and diagnostics

    • Cosmetics and food supplements

  • Process requires:

    • Dossier with safety/efficacy data

    • Labeling in Spanish

    • GMP certification

    • Certificate of free sale or foreign market approval

• Telecom Type Approval (CONATEL):

  • All telecom and RF devices must be type approved before use or import.

  • Approval requires:

    • Technical documentation

    • Test reports (CE or FCC accepted as support)

    • Application submission by a local representative

  • Approved devices are listed in CONATEL’s public registry.

• Labeling Requirements:

  • Labels must be in Spanish, and include:

    • Product name

    • Manufacturer/importer information

    • Country of origin

    • Instructions for use and safety warnings

    • Expiry or batch number (for food and health items)

    • Registration or approval ID (if applicable)

• Import Oversight:

  • Imports must be supported by:

    • Invoice and packing list

    • Certificate of origin

    • CoC or registration certificate (where applicable)

    • Type approval certificate (for telecom equipment)

• Market Surveillance:

  • Conducted by DNVS, CONATEL, and INTN. Inspectors perform spot checks, labeling audits, and compliance enforcement. Non-compliant goods may be recalled, banned, or fined.