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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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China Medical Device Regulations
SFDA regulations and other applicable regulations related to medical devices in China.
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Laboratory Automation (classified as IVD in EU) Classification in China?
Lu288
Jan 20, 2012
Replies
5
Views
3K
Jan 26, 2012
Lu288
L
P
Software Changes - Is an FDA guidance type of document available from SFDA (China)?
pnovit
Jan 11, 2012
Replies
2
Views
3K
Jan 18, 2012
Jamiechina
J
D
Class I Medical Device Registration (STED) requirements in China
delvynh
Sep 29, 2011
Replies
1
Views
4K
Sep 30, 2011
sreenu927
S
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SFDA Regulation of Medical Device Recall (Interim) - MOH decree No. 82
sreenu927
Jul 12, 2011
Replies
1
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4K
Aug 30, 2011
davjger
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Chinese Regulations for the Supervision and Administration of Medical Devices
davjger
Aug 1, 2011
Replies
2
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3K
Aug 2, 2011
davjger
D
C
SFDA Approval (China) - Changing Locations
Cinti
Jan 27, 2009
2
Replies
12
Views
7K
Feb 16, 2011
CBAL08
C
Design Controls for medical device exported from China
Ajit Basrur
Sep 20, 2010
Replies
5
Views
3K
Nov 18, 2010
Erik_
E
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Manufacturing Establishment License (China) for Medical Devices
Rocke
Mar 4, 2009
Replies
6
Views
5K
Jul 16, 2010
Rocke
R
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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