Mexico
Capitalise on the market opportunities in Mexico
Regulations 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.
Market access information by category
Click on the respective blue bars below to get market access information for each category.
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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 EFFICIENCY
- Minimum Energy Performance Standard (MEPS) are required for some products.
- Mandatory energy efficiency labelling is required for certain products.
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 MEPS level, or maximum limits of electrical power according to NOM standards.
Applicable product categories
Product categories that require mandatory labelling include:
- Air conditioners
- Clothes washers
- Freezers
- Lamps for general use
- Refrigerators
- Water heaters, etc.
Product categories that require mandatory maximum limits of electrical power:
- Audio playback equipment
- DVD
- Image reproduction equipment, including printers, scanners, fax machines, copiers and multifunctionals
- Microwave ovens Digital TV adapters
- Television set-top boxes
- Televisions
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.