CFDA updated five regulations to be effective from October 1, 2014

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L

Lotus_zou

#12
Hi all

Here is final list of class II clinical trial exempted medical device list.

Implementation date October 1, 2014.

Translated to English,

Cheers,
Thanks a lot for your sharing . How about the class III clinical trial exempted MD List?
 
L

Lotus_zou

#13
The second list is not list of device that needs clinical trial , but list of devices which need CFDA preapproval before clinical trial. Devices that not listed in the first list are suggested to conduct clinical trial activity.
 
L

Lotus_zou

#16
yes, I've attached it to this post.

I'm looking for the classification of medical devices and the precise definition of class I, II and III devices.

thank you.

thank you RKU38, but i notice the attached list is not the final issued list.
 
W

wfong3

#17
Hello rangani,
Do you know where i can find a copy of the english CFDA medical device registration form or the form is only available in chinese?

Thanks for your help!
 
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