A medical device refers to an instrument, device, device, material or other article suitable for the human body, alone or in combination, including the required software; its use for human body surface and in vivo is not obtained by pharmacological/immunological or metabolic means, However, these means may be involved and play a supporting role; their use is intended to achieve the following objectives:
(1) Prevention, diagnosis, treatment, monitoring, and relief of diseases.
(2) Diagnosis, treatment, monitoring, mitigation, and compensation for injury or disability.
(3) Examination, replacement (transplantation), and correction of human tissue or physiological processes.
(4) Pregnancy control.
The medical device industry is a multidisciplinary, knowledge-intensive, capital-intensive high-tech industry that is related to human life and health. Many medical devices are a combination of medicine and various disciplines. Its development level represents the comprehensive strength of a country. The level of scientific and technological development. There are many varieties of products in the medical device industry. The manufacturing technology involves many technical cross-cutting fields such as medicine, machinery (including metal processing industry), electronics and plastics. The scale of production varies from enterprise to enterprise. Large-scale high-end medical device products have high requirements on scientific and technological content and high value of individual products, and are suitable for small-scale production; small and medium-sized basic medical device products have high quality requirements and low value of individual products, and are suitable for mass production.
The medical device industry belongs to an industry closely related to human life and health. The demand is rigid, so the cyclical characteristics of the industry are not obvious. The impact of the economic downturn on the industry is not obvious, and the industry has strong anti-risk ability. In the global economic recession caused by the 2008 financial crisis, it was particularly evident. In the case of a significant decline in Chinese exports, the export of the medical device industry continued to grow rapidly.
The medical device industry's technological progress, enterprise growth and market expansion are closely related to the upstream and downstream industries. The technological advancement of the upstream industry will directly affect the technological direction of medical devices. The processing and manufacturing capabilities of the upstream industries of the country's basic industries, such as materials, electronics, machinery, non-ferrous metals and mold industries, determine the quality, technical level and cost of raw materials or semi-finished products. . China vigorously advocates scientific and technological progress and independent innovation, and achieves leap-forward development in the manufacturing fields such as mechatronics and precision manufacturing, laying a good foundation for the development of the medical device industry. The downstream industry determines market capacity, consumer demand and spending power, which affect and determine the quality, technology and economics of medical device products. The level of downstream industries such as medical organizations and the demand for medical services in the society are closely related to the development of the medical device industry. With the healthy development of China's national economy and the in-depth promotion of building a harmonious society, the investment in medical and health fields will increase substantially; with the substantial increase in residents' income, the ability to pay for medical costs will continue to strengthen, and the market demand for medical devices will continue to increase. Rapid growth.
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