The Mexican medical device industry is one of its most significant manufacturing sectors. Although Mexico manufacturers many medical devices, it imported product valued at US $2.0 billion in 2011, mainly from the U.S. U.S. manufacturers. These companies profit from their close proximity, and superior terms of trade under NAFTA. Mexico is the third largest importer of medical devices in the Americas, behind the U.S. and Canada. As regards its manufacturing capacity in this sector, Mexican labor produces general supplies, plastic and metal parts, disposable medical products, orthopedic products, medical instruments and surgical instruments. Since 1998, many U.S. medical device manufacturers initiated medical device manufacturing operations in Mexico. These companies include: Medtronic, Smiths, Tyco Healthcare, Cardinal Health, Medimexico, ICU Medical, Hudson ACI, Sunrise Medical, North Safety Products, Tristate, Lancer Orthodontics and In Flow.
Since the 1990’s, Mexico has emerged as the favored destination for design, development and manufacturing of medical devices. Ninety one of medical device investments come from U.S. Mexico’s cost competitiveness, highly skilled workforce, and intellectual property protections have encouraged many U.S. medical device technology companies to expand operations to Mexico. Importantly, Mexico has developed a very good working relationship with FDA.
The Secretariat of Health in Mexico regulates health products including medical devices. Mexico’s General Health Law mandates the importation and exportation of health products (medical devices, pharmaceuticals, drugs, biological products for human use) and food. The Federal Committee for Protection from Sanitary Risks (COFEPRIS) is the unit within the Health Secretariat that has received this charge and within its mandate also collects information regarding manufacturers importers, and distributors, as well as issues advertising permits for these products.
COFEPRIS issues Sanitary Registrations and Sanitary Authorizations for importation of medical devices and supplies. The Sanitary Authorization is an import permit, for which the contender must provide specific information about the shipment to be imported. The Sanitary Registration is the marketing authorization for medical devices. COFEPRIS usually takes several months to process registration. COFEPRIS’s mandate covers applying national health hazard protection policy; improving and exercising the regulation, control, sanitary surveillance and evaluation of health risks from products, activities and establishments under its competence; and carrying out the Health Ministry’s functions on the environmental impact on health, occupational health, hazardous residues, basic sanitation, accidents involving toxic, dangerous or radioactive substances and health protection in advertising. COFEPRIS, which was established in July 2001, comprises the following five integrated directorates: Medicinal Products and Health Technologies, Sanitary Control of Products and Services, Environmental and Occupational Health, Sanitary Control of Advertising, and the National Public Health Laboratory.
Since the development of the North American Free Trade Agreement (NAFTA) in 1994, the U.S. medical device exports to Mexico rose by 143%. By 2002, the Mexican domestic production of medical devices was valued at $78.6 billion. This accomplishment was credited to NAFTA’s advantageous clauses that provided for duty free imports, affordable qualified labor and increased cost competitiveness. NAFTA’s chief contribution improved the steadiness of the regulatory environment in Mexico. It also smoothed the way for increased flow of investments from the U.S. into Mexican assembly plants. Mexico offers strong opportunities for medical device manufacturers from the U.S., Europe and the Asia-Pacific region.
Mexico’s medical device industry has helped its domestic healthcare industry to improve products and services. Starting with medical device manufacturing, Mexico has moved towards developing advanced and innovative medical device applications. Design and manufacturing of quality products has supported the ability of Mexican doctors and other healthcare professionals to serve their patients better.
Requirements for medical device registration submissions to COFERIS are described in Articles 179 and 18 of the Reglamento de Insumos para la Salud. Documentary information that must be included in a registration submission: scientific and technical information that substantiate that the device complies with safety and effectiveness characteristics; the label in Spanish according to corresponding official Mexican norms or standards; the instructions for use in Spanish; the general description of the manufacturing process for the medical device; a description of the structure, materials, parts, and functions of the medical device; the laboratory tests to verify the specifications of the medical device; bibliographical references; references to corresponding official Mexican norms, if relevant.
If the manufacture of the device does not take place in Mexico, Article 180 specifies that the following supplementary information is required: a certification of free sale or counterpart issued by the health authority of the country of origin; an endorsement letter from the manufacturer, certified according to the legal procedures in the manufacturer’s country of origin; a good manufacturing practices guarantee issued by the health authority of the country of origin or equivalent medical device quality system certification; and a copy of the certification of analysis issued by the manufacturing company using the manufacturer’s letterhead and signed by the responsible quality control representative.
The minimum labeling requirements are found in the NOM, the information specified on the label must be in Spanish and must be legible and understandable. The generic and specific names of the device, country of origin, sanitary registration number, and expiration date, serial or lot number and contents must be on the label. If a third party for the sanitary registration holder manufactures the medical device the name of the third party must be included on the label.
Once the medical device registration has been reviewed and approved by COFEPRIS, the Mexican registration possessor or the manufacturer issues letters appointing other distributors to the registration. The process of transferring a medical device registration in Mexico is straightforward and discussed in Article 190 of Reglamento de Insumos para la Salud. There is an accompanying guidance on the topic. Once approved, the procedure grants permission for other distributors to approach COFEPRIS for an import license for those specific medical devices.