|
Medical devices and pharmaceuticals, is related to human health and life safety special commodity for human disease diagnosis, prevention, monitoring, treatment, mitigation and compensation, involving multi-disciplinary, technology widely in play at the same time, there is a the potential risk of adverse events, therefore, need a professional, systematic, workable laws and regulations to ensure their safety and efficacy to be guaranteed. April 1, 2000, with the \Subsequently, the State Food and Drug Administration issued a 15 supporting administrative rules, the basic form with Chinese characteristics, medical equipment management laws and regulations. But with the development of medical device industry and the health care needs of the masses continues to improve, \Such as the definition of medical devices is not comprehensive, scientific classification, product registration is not uniform, low standard, national, provincial, city (prefecture) and county four management levels is unclear, the operation of medical devices, the use of behavioral requirements are very simple. penalties for violations on the part of the amplitude is too general, operability is not strong, and the \Even some of the problems encountered in the daily supervision of the existing regulations could not find a legal basis. Papers from the six parts for medical devices and daily supervision of legal problems encountered in the analysis, discussion, Europe and other developed countries for medical device regulatory laws and regulations are introduced, and learn from their experiences, these issues put forward a sound countermeasures. The first part of medical device definition, classification and analysis of the problems, Europe and other developed countries introduced the definition and classification of medical devices features, and learn from their experience and our experience on the management of counterfeit drugs, improve our proposed definition of medical devices Suggestions and category management. The second part analyzes the safety and effectiveness of medical devices with standard relational, product registration, clinical trials, production and business management and other medical products premarket management situation and existing problems, learn from Europe and other developed countries, regulatory experience, put forward a sound Medical Management of the proposal prior to listing. The third part of the management for medical devices, such as listing using existing laws and regulations regulatory analysis of the issues, drawing on our experience in the management of post-marketing, proposes to strengthen the management of medical countermeasures and suggestions after the listing. The fourth part of the daily supervision of law enforcement for medical devices and analysis of the issues that exist for these problems, improve the daily supervision and enforcement of medical countermeasures and suggestions. The fifth part for breach of medical device regulatory liability, including administrative responsibilities, adverse event liability, criminal and other aspects to analyze problems, find the lack of existing laws and regulations, put forward a sound countermeasures. Part VI on \aspects of analysis, from the laws and regulations find the cause of these problems, learn from Europe and other developed countries, China's pharmaceutical management aspects of successful experience, combined with China's medical device regulatory practical recommendations to improve these problems countermeasures. Through legislation, enforcement levels and continuously improve the level of medical device regulation, in order to better meet the health care needs of the people to make their own contribution.
|