Do Mass Spectrometers fall under Medical Device Regulations in China?

R

RA2010

Hi everyone,

I'm looking for some guidance/ confirmation regarding China's regulation of IVD products. I understand that an IVD system would require an MD Registration Cert for the instrument and an IVD Reagent Registration Cert for the reagents. What about an instrument that is being sold for general clinical use? i.e. it will not be marketed for the diagnosis of a specific disease or condition and will not come with assays. Would the instrument still be registered as a medical device in China?

Thanks for any help!
 

Marc

Fully vaccinated are you?
Leader
A second "Bump". My Thanks in advance to anyone who can help with this one!
 
T

Tonyfang

Hi everyone,

I'm looking for some guidance/ confirmation regarding China's regulation of IVD products. I understand that an IVD system would require an MD Registration Cert for the instrument and an IVD Reagent Registration Cert for the reagents. What about an instrument that is being sold for general clinical use? i.e. it will not be marketed for the diagnosis of a specific disease or condition and will not come with assays. Would the instrument still be registered as a medical device in China?

Thanks for any help!
This still be registered as a medical device in China,class II
 

v9991

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