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Research on Current Situation and Improvement of Risk Management for Medical Device Laws & Regulations in China

Author: ShenQin
Tutor: XuYong
School: Suzhou University
Course: Public Health
Keywords: Medical Devices Risk Management Legislation
CLC: F203
Type: Master's thesis
Year: 2010
Downloads: 199
Quote: 0
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Abstract


Purpose : from a risk management point of view , China 's medical device regulations to conduct a comprehensive analysis to identify deficiencies and areas for improvement put forward development proposals on risk management of medical devices in China 's public health policy , strengthen risk management of medical devices , maintenance and protection of public life and health interests . Method : evidence-based analysis of the literature data . By analyzing the definition of medical devices, risk and risk management , revealed that five of the risk management of medical devices particularity ; application of risk management theory system of medical device regulation system , and our current medical device products listed and listed after all aspects of regulatory policy analysis to clarify the requirements of medical device regulatory control product risk . Results: China has initially established in order to pre-market approval , supervision and vigilance after the listing , as well as supervision of manufacturing enterprises as the core of the medical device regulatory system, and has established a national, provincial , city and county law enforcement agencies of the four medical devices and the team has established strong professional , independent of the operating system of multi - party technical support , and medical device adverse event monitoring and reporting system has been established , the overall risk of medical devices to prevent orderly . Compared with the developed areas of the world , China's medical equipment market risk management regulations and international basic standards, but after the listing of the overall risk management regulations are relatively weak , there are nine issues . Conclusion: China's medical equipment market , the overall risk management regulations are relatively weak , there are still many problems need to be identified by means of public policies and regulations of the Medical Device Risk measure , processing and evaluation , and gradually improve the risk management regulations , risk management throughout the medical equipment research and development, production , sales, and put into use after the whole process , so that the risk of medical equipment to a minimum , in order to protect people's armed security .

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CLC: > Economic > Economic planning and management > Management of National Economy > Production industry management
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