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Brazil

Capitalise on the market opportunities in Brazil

BrazilRegulations and compliance requirements can pose challenges to companies who are looking to export their new products to Brazil. These regulations and compliance requirements are put in place to provide assurance that the products and services are safe, of good quality and fit for consumers’ needs.

For most products entering the Brazilian territory, they must fulfil product regulations as stipulated by National Institute of Metrology, Standardisation and Industrial Quality, INMETRO. The INMETRO conformity mark is applicable to both voluntary and mandatory certification programmes.

You can ensure that your products successfully meet Brazilian standards by working with a market leader, TÜV SÜD. TÜV SÜD fully understands the local requirements and procedures applicable in Brazil. You can rely on our expertise and knowledge to help you access Brazilian 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 N

    Plug N

  • Electrical Safety

    Regulatory agency

    • National Institute of Metrology, Standardisation and Industrial Quality (INMETRO)

    Regulations

    • Mandatory testing and certification are required for certain regulated product categories.
    • Testing must be performed by a Product Certification Body that is accredited by INMETRO.
    • Initial and follow-up factory inspections are required for mandatory certification.
    • Products certified by an INMETRO-accredited body are required to carry the mandatory INMETRO Mark of the certification organisation.
    • Compliance with ABNT, NBR, NM and/or IEC Standards are also required.
    • Products must be marked with the INMETRO Mark.

    Guidelines

    • The INMETRO Mark can be applied to products under mandatory certification lists.
    • Test reports from INMETRO accredited laboratories and/or accredited bodies can be accepted:
      • Inter-American Accreditation Cooperation - IAAC
      • European Cooperation for Accreditation - EA
      • International Laboratory Accreditation Cooperation - ILAC

    Applicable product categories

    • Product categories that require mandatory certification include:
      • Circuit breakers
      • Electrical medical equipment
      • Electronic ballasts for fluorescent lights
      • Equipment for gas systems
      • Explosive atmosphere equipment
      • Household and similar electric appliances
      • Plugs and sockets
      • Street lighting using discharge lamps and LED technology
      • Switches
      • Voltage stabilisers
      • Wires and cables

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

  • Energy Efficiency

    Regulatory agency

    National Institute of Metrology, Standardisation and Industrial Quality (INMETRO)

    Regulations

    • Minimum Energy Performance Standards (MEPS) are required for some products.
    • Mandatory energy efficiency labelling is required for certain products.

    Guidelines

    • PROCEL is the national energy efficiency program and INMETRO is responsible for verifying manufacturers’ data.

    Applicable product categories

    Product categories requiring energy labelling include:

    • Air conditioners
    • Ceiling fans
    • Centrifugal pumps
    • Clothes washers
    • Column and air circulators
    • Commercial electric ovens
    • Compact fluorescent lamps
    • Electric water heating
    • Electromagnetic ballasts for high pressure sodium vapour lamps
    • Fan tables
    • Freezers
    • Gas stoves and furnaces
    • Gas water heaters
    • High pressure sodium vapour lamps
    • Incandescent lamps for domestic use
    • Microwave ovens
    • Refrigerators
    • Systems and equipment for photovoltaics
    • Televisions sets
    • Three-phase induction motors squirrel cage rotor

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

  • Medical Devices

    Regulatory agency

    • Brazilian National Health Surveillance Agency, Agência Nacional de Vigilância Sanitária (ANVISA)

    Regulations

    • All medical devices intended for sale in Brazil must be registered with ANVISA. Prior to registration at ANVISA, a BGMP inspection according to RDC 16/2013 at the manufacturing facility has to be performed for manufacturers of Class III and Class IV medical devices.
    • For most electrical and some non-electrical medical devices, INMETRO certification is also mandatory in order to achieve registration at ANVISA. Only test reports from certain accredited test laboratories, which are not older than two years from the date of certification, are accepted.
    • Products must be marked with the INMETRO Mark.

    Guidelines

    • A local legal representative who is responsible for INMETRO certification and registration at ANVISA is necessary.

    The following requirements are described in RDC 185/2001:

    • Technical Documentation to be submitted is to a large extent compliant with the Global Harmonisation Task Force Guidance (GHTF) for Summary Technical Documentation (STED). In addition, some further specific documents will be requested.
    • Medical device classification bears similarities to the EU Medical Device Directive.

    Applicable product categories

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

  • Telecom and Wireless

    Regulatory agency

    • Agência Nacional de Telecomunicações (ANATEL)

    Regulations

    • Approval is required for most telecommunications and wireless equipment.
    • CoC issued by designated CB (OCD) is required for imports, and ANATEL certification is required for the commercialisation and sale of products.
    • Modular approval is accepted for RF.
    • Testing must be performed by accredited in-country test laboratories.
    • Products must be marked with the ANATEL Mark.

    Guidelines

    • A local representative is required.
    • Conformity assessment to Brazilian standards is required to be performed by accredited CABs.
    • Approval requirements may differ depending on which 1 of the 3 categories the equipment is assigned to.
    • Type examination, product quality assurance, and total quality assurance procedures may be performed.

    Applicable product categories

    Approval is required for:

    • All DLL (E1, E3, etc.) equipment
    • All optical interfaces
    • All equipment connecting to the Integrated Services Digital Network (ISDN)
    • All telecommunication terminal equipment
    • All network equipment
    • A wide range of radio products

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

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