Research On Challenges And Solution Of Jilin Province's Medical Device Regulation

Medical equipment is related to people's health, and even the safety of a special commodity. Medical equipment is always the birth of new products with the most advanced technology with each other in various fields of new technologies in the medical field to the extensive application of medical device regulation to a constant flow of new challenges;假劣products means the manufacture and sale of constant renovation, the form of more hidden, the situation is more complex to combat the difficulty of constantly increasing, to bring new medical device regulatory issues. The face of problems and challenges, the management asked the Government to continue to improve the regulatory system, improve the monitoring means, to take effective measures to improve supervision.This article is divided into four parts, from the special nature of medical equipment products to start, highlight the equipment product safety, the importance of effective, detailed study of China's medical device regulatory system, and analysis of medical device regulation in our province the status quo, and through analysis of the United States EU medical device management system features, and with our existing regulatory system for medical devices are a comparative study to find the differences between, and then sum up experience, be inspired. The use of public management theory, and actively explore new medical device regulatory model, combined with medical equipment industry in Jilin Province and the supervision of the actual situation, the medical device can promote the rapid development of sustainable and healthy industry, but also ensures the safety of the product quality regulatory response.The first part is "the meaning of medical device regulation, the role of", which discusses in detail the meaning of government regulation, the definition of medical equipment, medical equipment and medical supervision of the meaning of the role of monitoring equipment;The second part is the "regulation of medical devices in Jilin Province Analysis", which mainly include three aspects: First, China's medical device regulatory status quo; Second, Jilin Province, the status of medical device regulation; Third, Jilin Province, the existence of medical device regulation the main issues and reasons.The third part is "the developed countries the regulatory status of medical equipment and enlightenment", which mainly include three aspects: First, the U.S. medical device status monitoring; Second, the EU regulatory status of medical equipment; Third, Europe and the United States and China's medical device regulatory differences and enlightenment.The fourth part is the "perfect medical device regulatory measures and recommendations", the main response from the four aspects: First, the legislative process to speed up medical equipment, medical equipment continue to improve the legal system of supervision; Second, keep a balance between clear functions and improve the medical device regulatory system; Third, strengthen capacity-building technical supervision to enhance the overall level of technical supervision; Fourth, innovation regulation, medical device products to strengthen the whole process of regulation; continuously improve the quality of personnel, law enforcement agencies to strengthen the building of grass-roots level.By analyzing the proof, come to the conclusion: China's medical device regulatory system compared with the developed countries there is still a gap. Ideas from the legislative, legal aspects, such as legal status, management structure to set up, system-building operational level there are a lot of problems and shortcomings. Regulation of medical devices cause a long way to go, can not be achieved overnight. With advances in medical technology and people's living standards, medical device regulation is bound to face greater challenges. Therefore, as government regulation of medical devices sector, need to continue to explore the law, sum up experience and improve the measures; to the supervision of a scientific concept, ahead of plan, strict law enforcement, regulation of medical devices to enhance the level of the masses in order to ensure the use of medical equipment safe and effective to make due contributions.