In Mexico, medical devices are categorized as Class I, II or III, based on the risk involved in their use.
Class I: Inputs known in the medical field, whose safety and effectiveness are proven and are normally not introduced into the body.
Class II: Inputs known in the medical field that are normally introduced into the body and remain for less than thirty days.
Class III: Inputs recently accepted in medical practice, which are introduced into the body and remain for more than thirty days.
The sector in Mexico produced 15.458 billion dollars in 2015.
Using data by Global Trade Atlas, Mexico exported 8.405 billion dollars in 2015, ranking as the eighth largest medical device exporter globally, the largest in Latin America and the leading supplier to the United States.
The main products exported from the sector were medical, surgical, dental or veterinary instruments and equipment, which accounted for 75.8% of Mexican medical devices exports.
In terms of global trade of medical devices, Mexico ranked:
•Third largest exporter globally of tubular suture needles.
•Fuorth largest exporter globally of medical, surgical, dental or veterinary furniture.
•Sixth largest exporter globally of syringes.
Companies Established in Mexico
In 2015, 2,393 economic units specializing in medical devices operated in Mexico, mainly located in the states of Mexico City, Estado de México, Baja California, Jalisco y Guanajuato.
The country's main cluster is located in Baja California, its companies account for 33% of total exports by the sector and are mainly engaged in equipment and component manufacturing and assembly.
The gradual increase in the number of employees in the medical device industry is a reflex of the growth of the industry. According to data by INEGI, 151,595 people were employed by this industry as of 2015.
Strengths of Mexican Medical Devices Industry
Mexico has development capacity and highly competitive human capital. According to the National Association of Universities and Higher Education Institutions information, annually 115 thousand students of engineering, manufacturing and construction graduated from Mexican institutions. Furthermore, there are about 777 educational programs related to biomedicine in the country.
KPMG's study Competitive Alternatives 2016 shows that Mexico offers savings of 21.2% in medical instrument manufacturing costs, compared to the United States. Furthermore, Mexico offers cost advantages in areas such as plastics manufacturing, metal components and precision manufacturing.
Mexico's location enables considerable savings in logistics and close monitoring of the manufacturing process; it facilitates plant inspection by health authorities and enables a rapid response to sudden changes in demand trends.