Views:391 Author:Site Editor Publish Time: 2020-09-30 Origin:Site
Medical devices refer to the instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related articles directly or indirectly utilized in human body, including the required computer software. For example, pelican speculum, tonsil forceps, straight eye scissors, etc.
The effectiveness of medical devices is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or they only play an auxiliary role although they are involved. Its purpose is the diagnosis, prevention, monitoring, treatment or remission of diseases, the diagnosis, monitoring, treatment, remission or functional compensation of injuries, the inspection, substitution, regulation or support of physiological structure or physiological process, life support or maintenance, pregnancy control, providing information for medical or diagnostic purposes by examining samples from the human body. Medical devices include capnography cannula, sims bivalve speculum, etc.
The medical device industry involves many industries, such as medicine, machinery, electronics, plastics and so on. It is a high-tech industry with interdisciplinary, knowledge intensive and capital intensive. The basic characteristics of high-tech medical equipment are digitization and computerization, which is the crystallization of multi-disciplinary and interdisciplinary modern high-tech. its products have high technology content and high profit. Therefore, it is the commanding height of the competition among the major countries of science and technology and international large-scale companies, and the threshold for intervention is high.
The State implements classified management of medical devices according to the degree of risk.
(1) The first is the low risk medical devices, which can be ensured by routine management.
(2) The second category is the medical devices with moderate risk, which need to be strictly controlled and managed to ensure their safety and effectiveness.
(3) The third category is the medical devices with high risk and need to take special measures to strictly control and manage them to ensure their safety and effectiveness.
Pain massage equipment, home health self-test equipment, blood pressure meter, electronic thermometer, multi-functional treatment instrument, laser treatment instrument, blood glucose meter, diabetes treatment instrument, vision improvement equipment, oral health products, family emergency treatment products, etc.
Electric massage chair/bed, massage stick, massage pillow, blood circulation machine, hand-held massager, therapeutic instrument, plantar physiotherapy instrument, beauty massager, etc.
Domestic cervical vertebra and lumbar vertebra traction device, traction chair, physiotherapy instrument, sleep instrument, massage instrument, functional chair, functional bed, medical inflatable air cushion, medical tape scissors, oxygen generator, high flow oxygen devices for home, decocting device, hearing aid, etc.
Family rehabilitation nursing assistant devices, female pregnancy and infant care products, family gas supply and transportation equipment; oxygen bag, family first-aid kit, blood pressure meter, blood glucose meter, nursing bed, etc.
Trauma disposal vehicle, operating table, monitor, anesthesia machine, ventilator, hematology analyzer, equipment used in ophthalmology, enzyme labeled instrument, phaco instruments, urine analyzer, ultrasound (color ultrasound, B-ultrasound, etc.), cottle septum speculum, X-ray machine, nuclear magnetic resonance, etc.
With the development of science and technology, patent products produced by some new manufacturers have also appeared in the market, including some commonly used household and hospital equipment, such as medical trauma disposal vehicles.
The medical device industry in China has experienced a process of development from scratch and from small to large, which is characterized by low starting point and rapid development. In recent years, the medical device industry in China has developed by leaps and bounds. According to a report, China has become the third largest medical device market in the world after the United States and Japan in 2005. In 2006, the import and export of medical devices in China exceeded the 10 billion US dollar mark for the first time, with a total value of 10.052 billion US dollars.