China Medical Device Labeling requirements - Language

kate

Registered
#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

Trusted Information Resource
#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
 

kate

Registered
#3
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
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

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

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?
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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