China radio frequency beauty devices have new technical review guidelines issued (No.8-2023) by the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) on April 12, 2023. The guidelines provide strict regulations for radio frequency (RF) beauty devices, in order to ensure that these products are safe and effective for use in beauty clinics, spas, homes, etc.
Manufacturers of radio frequency beauty devices must comply with the new technical review guidelines starting from April 1, 2024. This date marks the beginning of the transition period for the new regulations, which require manufacturers to perform feasibility studies and submit pre-market regulatory submissions demonstrating product safety and effectiveness, among other things.
Scope
Back in March 2022, the medical device classification catalogue was amended by the NMPA to reclassify class II radiofrequency devices for treatment of the skin surface under the classification code of 09-07-02 to class III radiofrequency devices for non-ablative treatments. It was already required that manufacturers, importers, and sellers of radiofrequency therapy equipment must obtain the respective medical device registration certificates in compliance with the new regulations from April 1, 2024, onwards. However, there were different views in the industry at that time as to whether home-use radio frequency beauty devices would be included whilst some believed that only RF beauty devices with medical indications would fall under the scope as medical devices.
The new guidelines clarified that radio frequency beauty equipment would cover both vertical or benchtop (large) radio frequency beauty equipment, as well as handheld (small) equipment:
- 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.
This would imply that home-use RF beauty devices would also be required to register as class III medical devices in China upon the date of implementation of the new guidelines.
Specification
In addition, the new guidelines addressed the electrical energy frequency specifications for RF beauty devices to produce a thermal effect on human tissues in general:
- Above 200kHz for radio frequency current
- 13.56 or 40.68 MHz for electric fields
The intended use of RF beauty devices have also been specified to treat skin laxity, reduce skin wrinkles, shrink pores, tighten/lifting skin tissue, or treat acne, scarring, or reduce fat (fat softening or breakdown), etc.
These guidelines do not apply to high frequency surgical devices used in the field of aesthetic surgery. Although these products also use high-frequency currents on the body, they achieve a cutting and coagulation effect, which is not the same as the mechanism of action of the RF devices described in this guideline.
Further information
Read the full CDME announcement on the new technical review guidelines for radio frequency beauty devices.
Cisema can help you comply with these new guidelines. Let us know if you would like to learn more about our registration, quality management, clinical research and testing services for medical devices and IVDs in China.
