As an important part of the medical and health system and medical and health service system,China medical regulations system has been completed and gradually perfected,and the basic system of medical product liability has been established.However,due to the complexity of the medical product itself,the variety of its products,and its application focus on the field of medical technology that is far away from the public,the provision of medical products and the provision of medical services are often closely related and indivisible.However,it is more unique due to the technical characteristics and industry characteristics of the medical industry.Furthermore,China’s reform of the medical product distribution system directly or indirectly affects the legislation of medical product liability.The medical product liability system reflects the interests of medical system reform.At present,the medical product distribution system is undergoing rapid adjustment.With the advancement of medical science and technology and the current defective medical product regulations also show a certain degree of limitation and lag,it needs to be overcome with appropriate methods in the implementation of specific laws.This article uses the aforementioned content as the background to discuss the outstanding problems of the defective medical product system in China,and attempts to explore the construction and improvement of China’s medical product liability system from the perspective of combining the theory of tort law with medical and legal practice.Specifically,the main content of this article is divided into the following five chapters:The first chapter is the introduction,which mainly summarizes the research status of liability for defective medical products at home and abroad.At present,compared with foreign tort law research,our research in the field of medical product infringement is dominated by theoretical research such as the principle of liability and the form of liability,but the research on specific types of products and medical behavior is still insufficient.The meaning is relatively lacking.Regarding the subject of liability,the form of liability,the existence of defects,and many other details that can have a substantial impact on the handling of disputes,the provisions are still absent.The second chapter summarizes the concept and characteristics of medical product liability.Defective medical product liability is the specific application of product liability in the field of medical infringement.The types and applicationmethods of medical products are complex and difficult to define uniformly;their design and use are often combined with the body’s orientation,and they have both therapeutic functions and varying degrees of side effects.In the production,the prescribed quality standards must be strictly implemented.Must be implemented by professional technicians and specialized agencies.These characteristics determine that the liability of medical products should not be applied as simple as fault-free liability as in the case of common product damage.The third chapter mainly analyzes the background,content and existing problems of China’s current medical product liability system.At present,the outstanding problems of the defective medical product system in China include the unreasonable principle of imputation,the unclear criteria for determining product defects,and the unreasonable definition of the responsibility of some subjects.The main contents are as follows: 1.The no-fault liability is uniformly applied to cases of defects caused by defective medical products.The system was originally designed to protect the interests of the victims,but its theoretical basis is not solid,and in practice there is a tendency to apply non-fault liability without distinction.Second,the research on specific types of products is obviously insufficient.Third,the definition of the responsible body of medical institutions is not clear.Fourth,the application of the development risk defense has yet to be clarified.The fourth chapter analyzes the related extraterritorial law research,focusing on the thoughts on the classification of product defects and the type of product liability in the Restatement of Tort Law in the United States.The "Restatement" aimed at the classification of product defects and established corresponding identification standards for them,which revealed us a useful way to deal with cases of defective medical products.The fifth chapter puts forward feasibility suggestions for improving China’s medical product liability legislation.Relevant concepts are carefully distinguished when applying laws,including medical product classification,defect identification standards,and the nature of the responsible body of medical institutions.Based on the concept of subdivision,different imputation principles are applied to different damage situations,and corresponding defect identification standards,liability forms,burden of proof,etc.are determined.Specific proposals that are feasible include: 1.Realizing the type of medical products by referring to the classification of registered drugs;2.Determining the type of product liability by distinguishing the types of product defects and clear judgment criteria;3.Determining by identifying the profit nature of medical institutions The nature of the responsible body of the medical institution;4.The circumstances under which the development risk defence is clearly applied.In short,we should gradually refine and improve relevant laws and regulations bydistinguishing situations and types.In the application of the law,based on the emphasis on the principle of uniform responsibility and the form of responsibility,we should learn from the beneficial experience of extraterritorial law and combine specific cases to deal with the responsibility in more detail,and correct the application of no fault liability for defective medical products in practice.way of doing.This itself is also a requirement and reflection of the fine implementation of the law. |