The Research On Legal Regulation Of Chinese In-use Medical Device Safety

With the improvement of medical technology and the development of scienceand technology, medical device is more and more involved in medical proceduressuch as diagnosis, treatment, and nursing. At the same time, the development oftechnology also makes the medical device more complicated and sophisticated.During use, medical device either directly gets in touch with human body, orinfluences the medical effect, so any failure can hurt patients, even cause deaths. Thesafety of in-use medical device has become one of the most important factors thatinfluence people’s life and health. Because lacking expertise in medical device andmedical technology, the public and the media always confuse medical deviceaccidents with medical accidents, so they pay less attention on the safety of in-usemedical device. Currently China’s in-use medical device regulation has the problemssuch as incomplete laws and regulations system, scattered regulation function,overlapping regulation responsibility, insufficient regulation capability building, lagregulation mode, lacking of regulation approach. Laws and regulations authority doesnot invest enough resources in safety regulation of in-use medical device. From alegal point of view, this paper focuses on three problems of in-use medical devicesafety regulation: main regulation body, regulation scope, and regulation mode.This paper mainly includes two parts: introduction and text. The introductionbriefly introduces purpose and background of this paper, as well as current research inthis area all over the world. The text has four parts. The first part mainly describes therelevant concepts of in-use medical device safety regulation and current in-usemedical device safety regulation legal system after the issue of “Medical DeviceSupervision and Administration Regulations” at the year2000. The necessity of in-usemedical device regulation is further illustrated by analyzing examples.By analyzingthe problems of existing main regulation body, the second part explains that bothgovernment and society are main responsible bodies for in-use medical deviceregulation. We propose a government’s food and drug regulation department leadingsafety regulation mode of in-use medical device with social organizations andinstitutions as supplements. It neither excessively depends on government, nor totallydepends on market and society. The third part studies the administrative powerallocation of in-use medical device between government and market under the marketeconomy. We propose three influencing factors for the scope of in-use medical devicesafety regulation: safety risk, administrative costs and benefits, and effectiveness. In addition, we redefine the boundary of regulation power. The fourth part presentspossible innovations for the traditional regulation mode by analyzing current in-usemedical device safety regulation mode and combining the concept of “building themost rigorous, whole-process-covering food and drug regulation system” in“CCPDecision on Major Issues Concerning Comprehensively Deepening Reforms”.