Peru has a comprehensive product compliance framework focused on mandatory technical standards, product registration, and import controls, especially for medical products, consumer electronics, food, and telecom devices. The country aligns many of its regulations with international standards (ISO, IEC, Codex) and regional trade agreements such as the Andean Community (CAN).

Key Authorities:

• Instituto Nacional de Calidad (INACAL) – Develops and promotes Peruvian Technical Standards (NTP) and oversees conformity assessment.

• Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) – Regulates pharmaceuticals, medical devices, and health supplements.

• Ministerio de Salud (MINSA) – Oversees public health, food safety, and cosmetics regulation.

• Ministerio de Transportes y Comunicaciones (MTC) – Manages type approval and spectrum regulation for telecom and RF devices.

• Superintendencia Nacional de Aduanas y de Administración Tributaria (SUNAT) – Enforces import documentation and border compliance.

Key Compliance Elements:

• Standards and Certification (INACAL):

  • Products subject to mandatory NTP standards include:

    • Electrical appliances

    • Construction materials

    • Personal protective equipment

    • Toys and household goods

  • Certification may involve:

    • Testing in accredited labs

    • Certificate of Conformity (CoC)

    • Local or international certification recognition

• Product Registration (DIGEMID / MINSA):

  • Mandatory for:

    • Medicines and vaccines

    • Medical devices and diagnostics

    • Food supplements and cosmetics

  • Requires:

    • Dossier with clinical or safety data

    • GMP/ISO certification

    • Certificate of free sale (from country of origin)

    • Labeling in Spanish

• Telecom Type Approval (MTC):

  • All RF and telecom devices must be type approved prior to import or sale.

  • CE/FCC reports may support applications, but local approval is required.

  • Approved products must be listed in the MTC’s type approval database and may require a Peruvian importer as the local applicant.

• Labeling Requirements:

  • Labels must be in Spanish, and include:

    • Product name

    • Country of origin

    • Manufacturer/importer details

    • Usage instructions and safety warnings

    • Expiry/batch number (if applicable)

    • Registration or approval number (for regulated goods)

• Import Oversight:

  • Imports must be supported by:

    • Invoice and packing list

    • Certificate of origin

    • Product registration certificate (if applicable)

    • Type approval certificate (for telecom)

    • CoC or lab test reports (for regulated categories)

• Market Surveillance:

  • Conducted by DIGEMID, MTC, INACAL, and customs, with inspections at ports, retail locations, and warehouses. Non-compliant goods may be fined, recalled, or blocked from sale.