Exploring Flow and Supervision of Medical Instruments by Standing on Frontier of the Reform of Free Trade Zone
10.3969/j.issn.1671-7104.2017.06.012
- VernacularTitle:站在自贸区改革的前沿,探索医疗器械流通监管
- Author:
Jianhua SHEN
1
;
Meixian HAN
;
Fei LU
Author Information
1. 上海市浦东新区市场监督管理局
- Keywords:
medical device;
circulation supervision;
risk analysis;
international supervision
- From:
Chinese Journal of Medical Instrumentation
2017;41(6):436-439,457
- CountryChina
- Language:Chinese
-
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.
