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China NMPA medical device submission timelines and clearance rates

#1
I will be submitting a standalone software device soon to NMPA. It is a major revision to the product previously registered with CFDA and will hopefully require only an Amendment to License. What is the typical turnaround time for med device submissions with NMPA over the last couple of years? I have one that's been in queue for 6 months with no response and am making a plan for the next product release. I've heard between 16 and 24 months is common.
 
#2
Hi Jesse,
I am assuming you are talking about a new international license for a class 2 device... then yes, the review time can exceed 12 months; not counting the time needed to handle deficiencies. I hope you have a good regulatory partner in China.

Shimon
 
#3
Hi Jesse,
I am assuming you are talking about a new international license for a class 2 device... then yes, the review time can exceed 12 months; not counting the time needed to handle deficiencies. I hope you have a good regulatory partner in China.

Shimon
Thanks for your prompt reply. Actually, it is class III in China. Thankfully, we have an office in China with experienced local RA/QA talent, but they are at an NMPA meeting all week and likely will not return correspondence until next week.
 
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