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Argentina

Capitalise on the market opportunities in Argentina

ArgentinaRegulations and compliance requirements can pose challenges to companies who are looking to export their new products in Argentina. Most products entering the Argentine markets must meet the requirements of the country. The local laws and product regulations are generally put in place to provide assurance that the products and services are safe, of good quality and fit for consumers’ needs.

Ensure that your products successfully meet Argentine standards by working with a market leader, TÜV SÜD. TÜV SÜD fully understands the local requirements and procedures applicable in Argentina. You can rely on our expertise and knowledge to help you access Argentine markets efficiently while at the same time, be assured of our objectivity, integrity and professionalism.

CLICK ON THE RESPECTIVE CATEGORIES BELOW TO GET MARKET ACCESS INFORMATION TO EACH CATEGORY

  • Plug Types

    Type C

    Plug C 

    Type I

    Plug I

  • Electrical Safety

    Regulatory agency

    • Instituto Argentino de Normalización y Certificación (IRAM) 

    Regulations

    • In accordance with Resolution 92/98, products to be sold in the domestic market are required to be certified by an organisation accredited by the Argentine Accreditation Body and recognised by the national authorities.
    • The mandatory S-Mark signifies that a product has been certified by an organisation accredited and authorised by the authorities.
    • Compliance with IEC standards.

    Guidelines

    • Manufacturers need to apply to IRAM and submit essential documents for safety approval.
    • Testing should be conducted to IEC standards for electrical and electronics equipment.
    • Initial and subsequent annual factory inspections are required for safety certification.

    Applicable product categories

    • All devices, apparatus or electrical materials intended to be used by consumers rated between 50V and 1000Vac or 1500Vdc require mandatory certification.
    • To determine if a particular product is subject to the above regulations, please contact us.

    Our services at a glance

    • TÜV SÜD can provide CB test reports that are accepted for safety approval through its MOU with IRAM.
  • Energy Efficiency

    Regulatory agency

    • Secretariat of Industry, Commerce and Mining

    Regulations

    • Household appliances within the scope of Resolution 319/99 must include a label stating their energy consumption level, to be determined using test methods indicated in the applicable IRAM standard.

    Guidelines

    • The law requires the information to be provided in a brochure and included with the instruction manual.
    • Efficiency is rated from A to G, with A being the most efficient.

    Applicable product categories

    Product categories requiring energy labelling include:

    • Air-conditioners
    • Dishwashers
    • Dryers Freezers
    • Electric storage water heaters
    • Fluorescent ballasts
    • Fluorescent lamps
    • Freezers
    • Microwave ovens
    • Refrigerators
    • Washing machines

    To determine if a particular product is subject to the above regulations, please contact us.

  • Medical Devices

    Regulatory agency

    • National Administration of Drugs, Foodstuffs and Medical Technology (ANMAT)

    Regulations

    • The domestic manufacture or import of medical products into the Argentine market must be registered with ANMAT, in conformity with MERCOSUR Technical Regulations for Registration of Medical Products.
    • All medical devices are required to meet the essential requirements in disposition 4306/99.
    • Good Manufacturing Practice (GMP) for medical devices should be applied and certified according to disposition 191/99.
    • A DoC with the MERCOSUR legislation is required for Class I devices.
    • A Certificate of Free Sale is required for all devices.
    • A risk analysis and clinical trials are also required for Class III and IV devices.

    Guidelines

    • An office or a local distributor in Argentina registered with the Ministry of Health is required.
    • Manufacturers are required to submit technical information with registration, including documents that are legalised by the Argentine Consulate or Embassy in the product’s country of origin.
    • Devices are divided based on the level of risk, into Class I, II, III and IV, with Class IV representing the highest risk.

    Applicable product categories

    • To determine if a particular product is subject to the above regulations, please contact us. 
    • Telecom and Wireless

      Regulatory agency

      • Ente Nacional de Comunicaciones (ENACOM)

      Regulations

      • Testing and approval is required for most telecommunication line terminal equipment and radio frequency equipment.
      • Approval may be in 2 forms - Homologación (approval to Argentine standards) or Codificación (accepted approval for which no standard exists).
      • Testing of equipment must be performed by accredited in-country test laboratories. Although foreign test reports are not accepted, they may speed up the approval process.
      • Approved telecommunication equipment is registered in the Registry of Activities and Materials of Telecommunications (RAMATEL). After the approval process, the information of the importers and their homologated/codified products will be automatically transferred to the RAMATEL Registry, controlled by the ENACOM.

      Guidelines

      • A local representative is required.
      • The Argentine importer or distributor must be registered with ENACOM in order to obtain certification.
      • Approved equipment will be listed on the ENACOM website.

      Applicable product categories

      Approval is required for:

      • All terminal equipment connected to the public telephone network
      • Low-power spread-spectrum products operating in the 2.4–2.4835 GHz band
      • Most radio equipment

      To determine if a particular product is subject to the above regulations, please contact us.


    WHY CHOOSE TÜV SÜD

    TÜV SÜD has the expertise and laboratory infrastructure to support manufacturers in obtaining the necessary approvals and compliance in accordance to the Argentina's standards and requirements. TÜV SÜD test reports are accepted for safety approval and recognised by relevant authorities internationally. TÜV SÜD also supports manufacturers in obtaining voluntary endorsement labels.

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