China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
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Software design document NMPA guidance and consultant
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4
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1K
TimZhao
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China Medical Device Labeling requirements - Language
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9
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4K
TimZhao
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Document Retention Policy for NMPA
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1
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1K
TimZhao
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B
Medical Device Labeling - Order No. 6 Effective Oct 01, 2014
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9
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6K
TimZhao
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NMPA translation requirements?
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3
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1K
TimZhao
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How to find a good online CFDA submission training?
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5
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1K
TimZhao
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IVD Label Change
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1
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560
Junn1992
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echo7tango
Circled-Z symbol on a syringe — what is it for, what does it mean?
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24
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8K
FRA 2 FDA
FRA 2 FDA
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Certification process for registered device
2
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12
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2K
Beth KL
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Rules of process outsourcing in China
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1
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984
RCSC NedTech
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IVD registration renewal in China
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6
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2K
shimonv
shimonv
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China - Start manufacturing before change approval?
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3
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2K
Ed Panek
Ed Panek
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Does anyone have experience of GB/T 34986-2017?
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1
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2K
Alice
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Where to buy English translation of Chinese Standard GB/T 14233
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8
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7K
Pancho
Pancho
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Advertising and promotion of device under investigation
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1
Views
950
shimonv
shimonv
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