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MeSH:(Device Approval)

1.Solution to Unify the Review of Domestic Second Class Medical Device.

Weiming QI ; Wenwu ZHU

Chinese Journal of Medical Instrumentation 2019;43(1):48-50

2.Study on the Medical Device Registration Submission Dossier Requirements in China.

Min CHEN ; Chenguang ZHANG ; Yinghui LIU ; Peng YUAN ; Gang DENG

Chinese Journal of Medical Instrumentation 2022;46(4):428-432

3.Preliminary discussion on the preparation of medical device standards adopting international standards.

Jia ZHENG ; Xinhua YU

Chinese Journal of Medical Instrumentation 2012;36(3):215-217

4.Analysis of the common problems of standards during medical devices registration.

Min YAN ; Li CAO ; Mingjun WU

Chinese Journal of Medical Instrumentation 2014;38(2):133-135

5.Analysis on current laws and regulations of medical device clinical trial in China.

Yue WANG ; Tianping LI ; Ningxia LIANG

Chinese Journal of Medical Instrumentation 2014;38(1):61-64

6.Reference and Innovation: Research on the Construction of Medical Device Registrar System.

Lai XU ; Senyong LIN ; Lijun HU ; Yihan YANG ; Zhong WU ; Jing HUANG ; Haihong JIANG

Chinese Journal of Medical Instrumentation 2019;43(3):192-196

7.Medical device registration system comparison between China and U.S.A.

Wei YUE

Chinese Journal of Medical Instrumentation 2009;33(1):51-58

8.Overview on the market, supervision and standardization of nanomaterial-contained medical devices.

Anliang SHAO ; Liming XU

Chinese Journal of Medical Instrumentation 2015;39(1):51-55

9.Administrative reform thinking on the regulations on the supervision and administration of medical devices.

Wei YUE

Chinese Journal of Medical Instrumentation 2014;38(5):357-360

10.Discourse of requirement for facility & environment in medical device quality system.

Hongguang LÜ

Chinese Journal of Medical Instrumentation 2012;36(3):218-221

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