The CMDE under the National Medical Products Administration (NMPA) of China has issued guidelines for registration and review of high-frequency beauty devices (No. 8[2023]).
Manufacturers of radio frequency beauty devices classified as Class III will have to comply with the new technical review guidelines from April 1, 2024.
The High Frequency beauty device Registration and Review Guidelines (No. 8[2023]) are briefly as follows.
1. The intended uses of RF beauty devices are skin relaxation treatment, skin wrinkle reduction, pore contraction, skin tissue strengthening/lifting, acne, scarring treatment, or fat reduction (fat softening or decomposing).
2. Electrical energy frequency specifications for RF beauty devices to create a thermal effect on human tissue are specified below.
- Above 200kHz for radio frequency current
- 13.56 or 40.68 MHz for electric fields
3. According to the notification requirements for adjusting the "Medical Device Classification List", it is classified as a Class 3 medical device with the 09-07-02 classification code.
4. The usage environment for high-frequency beauty devices is specified as follows.
- Vertical or benchtop (large) radio frequency beauty equipment should be limited for use in a professional medical institution environment (including medical beauty clinics).
- Handheld (small) equipment can be used in a home environment. (Home-use RF beauty devices would also be required to register as class III medical devices in China)
Likewise, high-frequency beauty devices are required to obtain a Class 3 medical device registration certificate from April 1, 2024.
Please refer to the attached file below for more information.
If you have any questions about medical device,
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