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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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Discussions
Medical device registration in China
Franky Zhang123
Nov 3, 2023
Replies
2
Views
431
Wednesday at 5:15 AM
Franky Zhang123
K
Returning Overseas Implantable Complaint Product to China
kah2018
Aug 2, 2023
Replies
1
Views
543
Feb 29, 2024
Daniel Zhang
D
The risk management standard of China's NMPA has been updated to GB/T 42062-2022 idt ISO 14971-2019
Franky Zhang123
Nov 21, 2023
Replies
1
Views
300
Feb 27, 2024
MIN LIM
M
G
TRANSITION PERIOD FOR ADAPTATION TO THE CHANGE OF VERSIONS OF INTERNATIONAL STANDARDS
Gledy Martinez
Jan 13, 2024
Replies
6
Views
380
Jan 30, 2024
Franky Zhang123
Q
An alternative way for NMPA registration if device does not have FDA approval
qualitynewbie
Jan 17, 2024
Replies
4
Views
254
Jan 26, 2024
qualitynewbie
Q
China representative
Franky Zhang123
Jan 16, 2024
Replies
0
Views
180
Jan 16, 2024
Franky Zhang123
Registration work flow
Franky Zhang123
Jan 16, 2024
Replies
0
Views
144
Jan 16, 2024
Franky Zhang123
The quality management system requirements of China's NMPA have been updated to GB/T 42061
Franky Zhang123
Nov 21, 2023
Replies
0
Views
484
Nov 21, 2023
Franky Zhang123
J
Importing Antibiotics into USA from China
jbm12
Nov 15, 2023
Replies
2
Views
280
Nov 20, 2023
Franky Zhang123
I
Is it possible to change IFU only for China?
IS1027
Jun 9, 2023
2
Replies
10
Views
1K
Sep 7, 2023
katezhang
K
I
Labeling requirements for Type Testing
IS1027
Jun 7, 2023
Replies
3
Views
708
Aug 15, 2023
RY0302
R
I
What is the final presentation dossier for the NMPA composed of?
IS1027
Jul 5, 2023
Replies
2
Views
584
Aug 1, 2023
Orca1
M
Classification of device according to China medical device regulations
mshah
May 24, 2023
Replies
4
Views
649
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
1
Views
650
Apr 20, 2023
Franky Zhang123
The Electrical Standards GB9706.1:2020 (same as IEC 60601-1:2012) etc. will be implemented on May 1st, 2023 in China.
Franky Zhang123
Mar 30, 2023
Replies
0
Views
599
Mar 30, 2023
Franky Zhang123
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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