Research On The Supervision Of Medical Equipment In China

In recent years, China's food and drug supervision departments implement severely the "Medical Equipment Regulatory Ordinance" and other regulations, increased medical equipment research and development, production, use and other aspects of the rectification and standardization. They has done a great deal of work and achieved significant results in ensuring medical equipments safe, effective, protect human health and safety. And medical equipment market is gradually standardized and legal track. However, as the regulation of medical equipments start work late, there were also exposed some problems. Therefore, it is of great realistic significance and urgency that how to correctly understand and handle the medical equipment monitoring.This paper expounds the medical equipment industries strengthen the need for government regulation. By means of "market failure", "government failure" and "government regulation theory", begin with the medical equipment industry and regulatory conditions. The paper analyses of the problems that exist in the current regulation of medical equipments and found, supervision and management is relatively weak because of China's medical equipment management functions scattered in several government departments, some medical equipment business units have illegal behavior because of the weak legal sense and weak self-discipline, some regulators'professional quality is weak and lack necessary medical equipment expertise, which bring more difficult to drug supervision, the supervision to some disposable sterile medical equipment and the third species of medical equipments that plant in human body is weak, which bring the hidden dangers to people's health and safety, grass-roots monitoring have a lot of difficulties because regulations isn't perfect. Based on the advanced experience from home and abroad, this paper put forward strategies and recommendations that improve medical equipment monitoring system, establish medical equipment adverse reaction reporting system, establish medical equipments mandatory recall system,and guide enterprises constructing the credibility, build medical equipment a long-term supervision mechanism.