China's Medical Equipment Safety Supervision And Countermeasures

As economic and social development, science and technology progress and people’s living standards constantly improving, growing demand for physical health and safety of the public in China, increasingly higher requirements for drug safety, mainly for daily use of medicals and medical devices application’s security is greatly concerned. However, frequent accident pharmaceuticals, medical devices exposed the conflicts between the safety regulatory capacity of supervision department and the growing safety demands of daily use of medicals of public. Currently, Our country is in a period of high incidence of medical safety risks and highlights, weak basis for administration of medical devices, medical devices regulatory work is facing a major test. Therefore, adaptation to the development of public administration in social transition period, strengthening and perfecting the mechanism of medical device safety regulation system, changing the regulatory concept, creative supervision’s way, improving supervision measures and supervision level has already been an important task for enhancing regulatory supervision capacity, credibility, influence, and meet the public’s growing security requirements as well.This article focus on the development and supervision of medical devices industry, use of "theory of government regulation", analysis the necessity of strengthening administration of medical devices, and elaboration of the current problems in china’s medical device safety regulation. We found that inadequate and weak legal status of medical devices regulatory, which did not match its corresponding responsibilities; imperfect institution affected regulation execution; technical support system for weak regulatory science was hard to play, informatization construction lag behind influenced regulatory efficiency, risk management mechanism was not sound regulating systemic; unbalanced regulation affected regulation efficiency;the social credit system construction lags behind social restriction effect was not obvious;miniaturization of enterprise objective intensified supervision difficulty.And on the base of draw lessons from foreign advanced experience,from the perspective of social regulatory policy analysis,put forward some countermeasures and suggestions.Hope that through regulation thinking innovation,further perfect the system of the medical device regulatory laws and regulations;to strengthen the construction of standard system,and improve the mechanism of rewards and punishments,optimization of policy implementation system,promote the medical device safety regulation of the public towards legalization and standardization step by step,to better safeguard the public with machinery is safe and effective.