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!
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!