CFDA - List of Class II Medical Devices exempt from Clinical Trials

[Aaria]

Does anyone have access to this list? I couldn't find it in the CFDA database.

Thanks,
Aaria

 

[medgar]

Re: CFDA: List of Class II devices exempt from clinical trials

Hi Aaria

The finalised lists have not been published yet. The draft lists are on this link

http://www.sda.gov.cn/WS01/CL0779/97818.html

My advice from my Chinese colleagues is that finalised lists should be available soon given the Regs have just been finalised.

 

[Aaria]

Thanks so much! This is very helpful.