The current situation and suggestions on the institutes for medical devices test in China
Yang, X.; Li, X.; Mu, R.; Wang, C.; Li, J.
Zhongguo Yi Liao Qi Xie Za Zhi 38(1): 57-60
2014
ISSN/ISBN: 1671-7104 PMID: 24839853 Document Number: 677507
This paper introduces the current status of Chinese medical device testing and inspection institutes. There are 53 such institutions, including 10 national institutions. Medical device testing and inspection institutions service in government regulation and supervision of medical devices, playing a technique support role for medical devices from registration before appear on market to monitor and supervision after listing. Meanwhile, they are important practitioners of medical devices standardization work. Finally, put forward the current problems and countermeasures of the inspection institutes in order to facilitate the sustainable development of our national medical equipment.