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Does cFDA accepts FDA approval or CE marking?

#1
I was wondering which are the main similarities. What can be reused? What is totally different?

Is the Chinese approval valid for other Asian countries?
 
#2
Submissions to NMPA (formally CFDA) is a pretty big deal and specific to the Chinese market.
The submission is done in Chinese according to NMPA content list and specific requirements.
You can certainly leverage on existing records and reports from CE/FDA submissions, but you don't get an automatic pass for any of them.

Shimon
 
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