China Medical Device Labeling requirements - Language

K

kate

Registered
#1
#1
Who is responsible for labeling products in Chinese? The legal representative in China or the foreign manufacturer?
Can products without Chinese label go through custom clearance?
 
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shimonv

shimonv

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#2
#2
As part of the submission process to NMPA (prior to marketing) you are supposed to include the labelling in Chinese.
I do not think that approved medical devices will pass customs without appropriate labelling in Chinese.

Shimon
 
K

kate

Registered
#3
#3
shimonv said:
As part of the submission process to NMPA (prior to marketing) you are supposed to include the labelling in Chinese.
I do not think that approved medical devices will pass customs without appropriate labelling in Chinese.

Shimon
Click to expand...
Thank you! So the foreign manufacturer will need to complete Chinese labeling prior to shipping to China. Correct?

What about devices being imported into China for clinical study (i.e. not approved by NMPA)? What is the labeling for these investigational devices? and who is responsible for such labeling?
 
shimonv

shimonv

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#4
#4
kate said:
Thank you! So the foreign manufacturer will need to complete Chinese labeling prior to shipping to China. Correct?
Click to expand...
Yes, its the manufacture's product and he has all the information that needs to go on the labelling (S/N, manufacturing date, etc.)

kate said:
What about devices being imported into China for clinical study (i.e. not approved by NMPA)? What is the labeling for these investigational devices? and who is responsible for such labeling?
Click to expand...
Investigational devices in China is somewhat complicated with several routs to bring in the investigational device. Either way, you will need to work with the receiving party in China, and in some of the cases you won't need a labelling in Chinese.
 
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