医疗器械注册及其收费形成机制研究

Research on Medical Device Registration and Its Charging Mechanism

我国医疗器械产品注册有利于鼓励产品创新、优化资源配置、落实主体责任,其成本补偿应由政府和特定主体共同承担。医疗器械注册收费标准的确定是在成本补偿机制作用下由直接成本及政府扶植和激励政策取向而确定。在优化营商环境机制作用下,我国多地省市价格管理部门下调医疗器械产品注册收费标准。建议将区域性产业优势与医疗器械产品注册标准相结合,把握好地区间的均衡;将医疗器械注册收费标准和改革注册审评审批体制相结合,合理制定注册收费标准;将成本补偿与营商环境优化原则相结合,兼顾公平与效益,进一步完善医疗器械产品注册制度。

The registration of medical devices in China was conducive to encouraging product innovation,optimizing resource allocation and fulfilling the principal responsibility.The cost compensation should be shared by the government and the specific subject.The standard of medical device registration fee was determined by the direct cost and the orientation of government support and incentive policies under the cost compensation mechanism.Under the mechanism of improving the business environment,the price management departments of many provinces and municipalities in China have lowered the registration fee standards for medical devices.It was suggested to combine the regional industrial advantages with the registration standards of medical device products to keep the balance between regions.Combine the registration fee standard of medical devices with the reform of the registration examination and approval system,establish the registration fee standard reasonably.Combine the principle of cost compensation with the principle of business environment optimization,give consideration to fairness and efficiency and further improve the medical device product registration system.