For medical device license when, the quality of the person in charge of the requirements of college education or intermediate title, related professional more than three years of relevant quality management experience; the other personnel, although there is no clear educational requirements, but it is recommended that the secondary school or high school education.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software.
Medical devices include medical equipment and medical consumables.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
Purpose is the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the testing, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
The medical device industry involves a number of industries such as pharmaceuticals, machinery, electronics, plastics, etc. It is a multidisciplinary, knowledge-intensive and capital-intensive high-tech industry. The basic feature of high-tech medical equipment is digitalization and computerization, which is the crystallization of modern high technology of multi-disciplinary and cross-field.
High profits, and therefore the various scientific and technological powers, large international companies compete with each other on the high ground, the entry threshold is high. Even in the industry as a whole, the gross margin is low, the input is not high sub-industry will continue to have a higher technological content of the product, and from this spawned a number of companies with strong profitability. Therefore, the overall trend of the industry is high input, high yield.