June 12, 2018
During the end of May, the CNDA redefined the management and classification of the intense pulsed light device (hereinafter referred to as "IPL devices") which is intended for hair removal. This kind of IPL device is now classified under Class II medical devices, with the amended classification code: 09- 03-04.
The notice also clearly requires that the components, the working principle, and therapy mechanism of the IPL device. The applied IPL device shall fully meet the requirements and shall not exceed the scope.
The establishments involved in the manufacture, importation, sale and distribution of IPL devices shall assume major responsibilities in ensuring product quality and safety. Moreover, they shall guarantee that the IPL products on market are safe and effective.