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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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R
Information on obtaining a market authorization for China
RichardJ_CH
Oct 1, 2020
Replies
2
Views
1K
Oct 5, 2020
RichardJ_CH
R
F
Change to Formulation due to Reach (China Medical Device Regulations)
Fivel75
Sep 2, 2020
Replies
0
Views
2K
Sep 2, 2020
Fivel75
F
O
Radio Modular approval in China
occounty
Jul 31, 2020
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0
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1K
Jul 31, 2020
occounty
O
I
Selling medical gown and mask in China
ivymama
Mar 19, 2020
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0
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1K
Mar 19, 2020
ivymama
I
C
Looking for China Good manufacturing practice
Choi Kyoung-Ho
Dec 11, 2019
Replies
1
Views
2K
Dec 12, 2019
Tagin
Q
Interpreting China Medical Device regulations/standards
QSEngineer20850
Nov 4, 2019
Replies
1
Views
2K
Nov 5, 2019
shimonv
J
China NMPA medical device submission timelines and clearance rates
Jesse Shearin
Sep 23, 2019
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2
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2K
Sep 24, 2019
Jesse Shearin
J
K
China UDI Implementation for October 1st 2019
kreid
Aug 30, 2019
Replies
4
Views
2K
Aug 30, 2019
JoshuaFroud
M
Does cFDA accepts FDA approval or CE marking?
mgloria
Aug 20, 2019
Replies
1
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2K
Aug 20, 2019
shimonv
D
Document review on already approved registrations requested by China's NMPA?
Dimonblade
Jul 31, 2019
Replies
3
Views
2K
Aug 1, 2019
shimonv
J
Change management with CFDA approved devices
JDVERT
Jul 2, 2019
Replies
1
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2K
Jul 4, 2019
shimonv
K
Registering a Software medical device (SaMD) in China
kreid
Jun 8, 2018
Replies
5
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3K
Jun 24, 2019
swathi.sp
S
E
Original Brand Labeler (OBL) in China
Edugar
Apr 17, 2019
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2
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2K
Apr 25, 2019
bermed
B
China - CFDA is now National Medical Products Administration or NMPA
Marc
Mar 20, 2019
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7
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3K
Apr 10, 2019
WendyLu33
W
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Medical device Clinical trial exemption list
tofm2
Apr 4, 2019
Replies
2
Views
2K
Apr 10, 2019
tofm2
T
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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