Legal Construction Of Medical Device Supervision

Medical device safety is of great importance for public health. Market forces alone are unable to ensure the safety of medical devices, so they need to seek help from the outside. So in order to protect public health, the medical devices regulatory legal system should be established. By providing medical devices of statutory standards and premarket and postmarket medical device regulation, the medical devices regulatory legal system will ensure the safety of medical devices. Although medical device regulation can ensure the safety of medical devices and protect public health, medical device regulation hinders patients’ early use of new type of medical devices and imposes some burden on medical device market, which makes medical devices regulation a theoretical and practical controversy. Therefore, exploring the theoretical foundation of the medical device regulatory, changing regulatory concept and improving the system of medical device regulation became an important task to enhance influence and credibility of medical device regulation and meet public demand for medical device safety This article is divided into four parts to analyze this topic, including the theory of medical device regulation and concrete systems.The first part expounds the concepts involved in the regulation of medical devices, and simply reviews and summarizes China’s medical device regulation’s historical development. This part also introduces the status quo of medical device regulation in our country. China’s medical device regulation can be divided into two parts: pre-market and post-marketing regulation. The pre-market regulation includes category management, pre-market licensing, and post-market regulation includes on-site inspection, supervision of sample testing, license management, monitoring of adverse reactions and so on. This part points out the problems existing in the medical device regulation in our country. These problems include: the lack of medical device regulatory theory foundation of the analysis, the lack of the analysis of the medical device regulatory purpose, and some problems in the specific medical device regulatory system.The second part analyzes the necessity of regulation of medical devices and medical device regulatory limits of theoretically. Medical device market failure provide the need for government regulation. Human reason is limited, and it is impossible to design a regulatory system to ensure the absolute safety of medical devices. Medical regulation has the problem of "degree". We should "rationally" treat the medical device regulation, and whether too stringent or too loose is not desirable, and we should seek a balance between too tight and too loose.The third part analyzes the experience of the regulatory laws and regulations, category management and pre-market approval in the United States, EU and Japan, pointing out that our country should increase the medical device regulatory legislation status, improve the classification of medical devices, and improve medical device pre-market approval.In the fourth part, this paper puts forward some suggestions to improve medical device regulation. These recommendations include: the establishment of the principle of medical device regulation legislation, including the principle of proportionality, the principle of centralized regulation, the principle of balancing of public interest and the principle classified regulation; to make clear plurality of medical devices regulatory purposes, and pay attention to the overall consideration in the design of relevant systems; to improve specific system...