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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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K
Returning Overseas Implantable Complaint Product to China
kah2018
Aug 2, 2023
Replies
1
Views
695
Feb 29, 2024
Daniel Zhang
D
G
TRANSITION PERIOD FOR ADAPTATION TO THE CHANGE OF VERSIONS OF INTERNATIONAL STANDARDS
Gledy Martinez
Jan 13, 2024
Replies
3
Views
485
Jan 29, 2024
qualitynewbie
Q
Q
An alternative way for NMPA registration if device does not have FDA approval
qualitynewbie
Jan 17, 2024
Replies
3
Views
352
Jan 26, 2024
qualitynewbie
Q
J
Importing Antibiotics into USA from China
jbm12
Nov 15, 2023
Replies
1
Views
355
Nov 15, 2023
Randy
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Is it possible to change IFU only for China?
IS1027
Jun 9, 2023
Replies
9
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1K
Sep 7, 2023
katezhang
K
I
Labeling requirements for Type Testing
IS1027
Jun 7, 2023
Replies
2
Views
786
Aug 15, 2023
RY0302
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What is the final presentation dossier for the NMPA composed of?
IS1027
Jul 5, 2023
Replies
1
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669
Aug 1, 2023
Orca1
M
Classification of device according to China medical device regulations
mshah
May 24, 2023
Replies
4
Views
725
May 28, 2023
ivan liu
I
K
Whether the product can be sold after being returned to the factory for upgrading
kingkingwang
Apr 18, 2023
Replies
0
Views
716
Apr 18, 2023
kingkingwang
K
C
Is there a definition of accessories for medical devices in China?
cool1984
Jun 1, 2022
Replies
2
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1K
Mar 29, 2023
UTGene
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GB9706.1:2020 - in-country testing
RA_QA_Expert
Jan 14, 2022
Replies
3
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2K
Mar 10, 2023
TimZhao
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China registration update medical devices
GiuliaGe
Feb 9, 2023
Replies
3
Views
685
Feb 9, 2023
shimonv
A
NMPA registered device VS country of origin (free sales certificate)
Azhar Anwar
Nov 29, 2022
Replies
4
Views
1K
Dec 21, 2022
Azhar Anwar
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A
Outsourcing registration to a local company
Amit Bechar
Oct 27, 2021
Replies
1
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2K
Jun 10, 2022
TimZhao
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Issue with free sales certificate for implants from China
OPME Brazil
Jan 7, 2022
Replies
1
Views
1K
Jun 10, 2022
TimZhao
T
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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