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Mexico

Capitalise on the market opportunities in Mexico

MexicoRegulations and compliance requirements can pose challenges to companies who are looking to export their products to Mexico. Most products entering the Mexico markets must meet the Norma Oficial Mexicana (NOM) mark requirements. 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 Mexican standards by working with a market leader, TÜV SÜD. TÜV SÜD fully understands the local requirements and procedures applicable in Mexico. You can rely on our expertise and knowledge to help you access Mexican 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 A

    Plug A

    Type B

    Plug B

  • Electrical Safety

    Regulatory agency

    • Secretariat of Commerce and Industrial Promotion (SECOFI)

    Regulations

    • Manufacturers are required to obtain NOM Certification for regulated products.
    • All electrical products, domestic or imported, must meet NOM requirements.
    • Testing must be performed by an accredited Mexican testing agency or a laboratory outside of Mexico that has a MRA with an accredited Mexican laboratory.
    • The CBs in Mexico that administer NOM certification are NYCE and ANCE.
    • Compliance with NOM standards.

    Guidelines 

    • A local representative is required.
    • Essential documentation has to be submitted to the CB for certification.
    • Post-market surveillance after obtaining certification is required.

    Applicable product categories

    • The NOM certificate applies to over 2000 product categories from electronics to household appliances.
    • To determine if a particular product is subject to the above regulations, please contact us. 

    Our services at a glance

    • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance according to the Mexican NOM requirements and obtaining the necessary approval.
  • Energy Efficiency

    Regulatory agency

    • The National Commission for the Efficient use of Energy (CONUEE)

    Regulations

    ENERGY CONSUMPTION
    • CONUEE approved the catalogue of equipment and devices in relation to which manufacturers, importers, distributors and retailers must provide energy consumption information in 2017. The information included must be in a clear and concise manner and must consist of:
      • Unit of energy consumption for operating time;
      • Type of energy or energy used in units of measurement unless, due to the nature of the product, the type of energy is clearly identifiable;
    • Quantity of the good, product or service of the equipment per unit of energy consumed where applicable.

    MAXIMUM LIMITS OF ELECTRICAL POWER

    • After 20 September 2014, all devices covered by the NOM- 032-ENER-2013 will start to be certified in accordance with the NOM.

    Guidelines

    • Products are rated based on the percentage of energy savings relative to the energy consumption, or maximum limits of electrical power according to NOM standards.

    Applicable product categories

    Energy consumption information must be provided for these equipment and appliances:

    • Amplifier
    • Mixer
    • Industrial water pump
    • Commercial / domestic coffee machine
    • Boiler
    • Industrial water center, etc.

    Product categories that require mandatory maximum limits of electrical power:

    • Audio playback equipment
    • Image reproduction equipment, including printers, scanners, fax machines, copiers and multifunctionals
    • Microwave ovens Digital TV adapters
    • Television set-top boxes
    • Televisions
    • Video or home theater equipment in DVD or Blu-ray formats

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

    Our services at a glance

    TÜV SÜD has the experience and capability to support manufacturers in attaining compliance according to the Mexican NOM requirements and obtaining the necessary approval. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels.

  • Medical Devices

    Regulatory agencY

    • Mexican Ministry of Health, Federal Commission for the Protection against Sanitary Risk (COFEPRIS)

    Regulations

    • To be imported into Mexico, all medical or health care products that come into contact with the human body must be registered with the Mexican Secretariat of Health (COFEPRIS).
    • ISO 13485 certification or official proof of compliance with US FDA QSR or another national quality system standard is required for all devices except for some Class I devices.
    • Products and consumerables which do not fall under the registration scheme for medical devices are on the list of "deregulated devices".
    • Certain electrical medical devices must undergo testing to obtain NOM Mark certification.
    • Clinical data and biocompatibility testing is required for Class III devices.

    Guidelines

    • A local representative is required.
    • For Mexican Registration Holders (MRH), a registration dossier needs to be submitted to COFEPRIS.
    • Upon certification, confirmation of the completed registration will be posted on the Ministry of Health website.
    • Medical devices are classified into 3 classes of increasing risk, Class I, II and III.

    Applicable product categories

    • This registration is required for wound care materials, surgical devices or material, hygienic products, dentistry products, family planning products, implantable prosthesis, diagnostic agents, reagents, medical equipment and instruments, external prosthesis, orthosis and functional aids.
    • To determine if a particular product is subject to the above regulations, please contact us.

    Our services at a glance

    • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance according to the Mexican requirements and obtaining the necessary approval.
  • Telecom & Wireless

    Regulatory agency

    • Federal Institute of Telecommunication (IFETEL)

    Regulations

    • All products that use a frequency to transmit and/or receive signals and all telecom products that connect to the PSTN or public network must be certified by IFETEL.
    • All products approved under the IFETEL Scheme should be labelled as follows:
      • For products with on-board/integrated radios: “IFETEL: xxxxxxxxxxxxx”
      • For host products containing approved modules: “This product contains an Approved module, Model No. xxxx, IFETEL No. xxxxxxxxxxxxx

    Guidelines

    • A local representative is required.
    • In-country testing is performed in EMA accredited laboratories.
    • Two samples of the following are required: Cables, power source, movable antenna, amplifier, testing software including procedures, technical specifications, installation and operation manuals.
    • Certification of a family of models is not allowed. Testing, certification and IFETEL registration is required for each product and model.

    Applicable product categories

    • All telecommunication equipment including wireless products. To determine if a particular product is subject to the above regulations, please contact us.

    Our services at a glance

    • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance according to the Mexican NOM requirements and obtaining the necessary approval.
       

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