站在自贸区改革的前沿,探索医疗器械流通监管

      Exploring Flow and Supervision of Medical Instruments by Standing on Frontier of the Reform of Free Trade Zone

      • 摘要: 上海外高桥保税区作为中国(上海)自由贸易试验区海关特殊监管区域之一,集聚了大量从事医疗器械的总代理企业。为进一步贯彻落实国家行政审批改革,加强事中事后监管的要求,该文针对自贸区中上海外高桥保税区特殊环境和医疗器械经营企业特点进行风险分析,并根据当前医疗器械法规新要求及医疗器械行业发展趋势,在研究各国市场化监督惯例基础上,提出实施精准监管、协同监管、分类监管及动态监管等措施,为形成公平规范的市场竞争新秩序,打造国际医药分拨和运输枢纽创造条件。

         

        Abstract: Shanghai Waigaoqiao Free Trade Zone as one of the special customs supervision areas of China (Shanghai) free trade pilot area, gathered a large number of general agent enterprises related to medical apparatus and instruments. This article analyzes the characteristics of special environment and medical equipment business in Shanghai Waigaoqiao Free Trade Zone in order to further implement the national administrative examination and approval reform. According to the latest requirement in laws and regulations of medical instruments, and trend of development in the industry of medical instruments, as well as research on the basis of practices of market supervision in countries around the world, this article also proposes measures about precision supervision, coordination of supervision, classification supervision and dynamic supervision to establish a new order of fair and standardized competition in market, and create conditions for establishment of allocation and transport hub of international medicine.

         

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