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?
Thanks
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?
Thanks