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Medical Equipment

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Medical Equipment
Medical Equipment
Introduction
Mexico imported medical equipment, instruments, disposable and dental products worth US $3.5 billion in 2010. This represented 90 percent of the medical equipment and instrument market and 2 percent of the disposables. Of these imports 57 %, or US$ 2 billion, were of U.S. origin. The main foreign suppliers of medical devices are Belgium, Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Netherlands, South Korea and UK.
U.S. medical products are highly regarded in Mexico due to their high quality, after sales service, and price point compared to competing products of similar quality. Consequently, U.S. medical equipment and instruments have a competitive advantage and are in high demand in Mexico.
Public health care institutions account for 70 – 80 percent of total medical services provided nationwide while private health care institutions cover approximately 25-30 percent of the Mexican population, including 32 million people with private medical and accident insurance. In 2007, Mexico had 3,140 accredited private hospitals, of which only 80 had more than 50 beds and the capacity to offer highly specialized services.
According to the article 83 of the Health products regulation, there is a risk-based classification of medical devices:
• Class I devices: Defined as those that “are very well known in the medical field, with proven effectiveness and safety, and that generally are not introduced into the human body.”
• Class II devices: Defined as “well known in the medical field, but may have a variation in the raw materials of which they are made, or different component composition or concentration, and that are introduced into and kept in the human body for less than thirty days.”
• Class III devices: Defined as “new products or products recently approved in the medical field, or products that are introduced and kept in the human body for more than thirty days.
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