Classification of device according to China medical device regulations


Hi all,
The MD manufacturer I work for are considering entering the med dev market in China.
The device is a Class IIb active therapeutic device intended to administer energy (pigment removal system) in the EU.
Looking at the classification in China I am unsure if this would be a Class II or Class III device. Could someone help determine which it would likely be?
Also is there any way of finding out if there is already a predicate device on the market in China?


it is a laser tattoo removal system. It is intended to be used for pigments and pigmented lesions from skin of various colors, as well as for tattoo removal from skin of various colors. The laser system is indicated for the following –
 Removal of the pigments and pigmented lesions for Fitzpatrick skin types I–VI with the Nd-YAG laser.
 Removal of pigments and pigmented lesions for Fitzpatrick skin types I–III of all colors with the combined Nd-YAG and Ti:Sapphire laser.


Class III.
there is predicate device in China, but I am not sure you could get its technical requirement files legally.
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