Laboratory Automation (classified as IVD in EU) Classification in China?

L

Lu288

#1
Hi all, I am new in this forum
I am from Italy and I am trying to classify a device that must be sold in China.
We produce a laboratory automation which in EU is classified as an IVD; the device simply transports blood samples contained in tubes, does not use reagents.

How could I classify it?
I think it is class I, can someone help me?

Thanks all!
 
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B

Bob 666

#4
Thank you but I'm still confused :confused: A laboratory automtion system falls under class I or II. Can someone help on the definitions of Form of Operation?
Basically or no Impact -Indirect Impact -Substantial Impact.
What are the meaning of the three categories?
Thank you!
 

v9991

Trusted Information Resource
#5
Thank you but I'm still confused :confused: A laboratory automtion system falls under class I or II. Can someone help on the definitions of Form of Operation?
Basically or no Impact -Indirect Impact -Substantial Impact.
What are the meaning of the three categories?
Thank you!
It depends on the function of your device..i.e., It depends upon the mode of use (or stated purpose of use); how does it help the product to meet the recommended conditions (or avoiding the risks/hazards to product);
let me give a wild guess...(& over simplification)
during transportation, a test tube stand(no contact) is different from a container(no contact) which provides adequate temperature conditions;
if it was test tube stand then class-I would be appropriate; & Class-II for a container providing controlled temperature.

hope that helps.
 
L

Lu288

#6
Thank you,
now it is quite clear!
I think our device is class I.

Does anyone have experience in exporting class I devices in China? Is it true that no local tests are needed?
We heard that it is formally true but that SFDA usually asks for some sample to test in their laboratories ...

Thank you all!
 
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