Suppr超能文献

站在自由贸易区改革前沿探索医疗器械的流通与监管

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

作者信息

Shen Jianhua, Han Meixian, Lu Fei

机构信息

Pudong New Area Market Supervision and Administration Bureau of Shanghai, Shanghai, 200135.

出版信息

Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Nov 30;41(6):436-439. doi: 10.3969/j.issn.1671-7104.2017.06.012.

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.

摘要

上海外高桥保税区作为中国(上海)自由贸易试验区的特殊海关监管区域之一,聚集了大量医疗器械相关的总代理企业。本文分析上海外高桥保税区的特殊环境和医疗器械业务特点,以进一步落实国家行政审批改革。依据医疗器械法律法规的最新要求、医疗器械行业的发展趋势,以及对世界各国市场监管实践的研究,本文还提出精准监管、协同监管、分类监管和动态监管措施,以建立公平规范的市场竞争新秩序,为建立国际药品调配和运输枢纽创造条件。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验