Medical device industry is a multidisciplinary, knowledge-intensive, capital-intensive high-tech industry with high entry threshold. The development status of medical device industry is a reflection of a country's comprehensive industrial level, which deeply integrates traditional industry with high-tech achievements in biomedical engineering, electronic information technology and modern medical technology.

According to Article 103 of the Regulations for the Supervision and Administration of Medical Devices, medical devices refer to 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.

The utility of medical devices is mainly obtained through physical means, and its purposes include: diagnosis, prevention, supervision, treatment or alleviation of diseases; diagnosis, supervision, treatment, alleviation or functional compensation of injuries; examination, substitution, regulation or support of physiological structures or physiological processes; support or maintenance of life; pregnancy control; and provision of medical or diagnostic information through the examination of samples from the human body. information, etc.

Medical devices are categorized into four major groups according to their product characteristics: medical devices, in vitro diagnostics, high-value consumables, low-value consumables, etc., wherein medical devices refer to instruments, equipment, appliances, materials, or other items used in the human body, either alone or in combination, and also include the required software.

Compared with developed countries, China's medical device industry has a weak foundation, small scale and lagging development. China's medical device industry is gradually developed after the founding of the country, during which it has experienced a development process from scratch, from small to large, characterized by a low starting point and rapid development.