According to Announcement No. 30-2022, RF therapy and RF skin therapy devices (Product code #09-07-02) shall be regulated as Class III medical devices.
Announcement No. 30-2022 mainly provided new requirements of the classification and regulation of RF devices intended to be used in the aesthetic field. The following aspects represent the current thinking of NMPA.
1.Not all RF products are regulated as medical devices.
2. If the device satisfies any of the following scenarios, they shall be regulated as Class III devices.
a)The working principle of RF therapy devices and RF skin therapy products is “to apply radiofrequency energy to human skin and subcutaneous tissue through treatment electrodes, causing pathological changes in human tissues and cells / Physiological changes”;
b)Intended to be “used to treat skin laxity, reduce skin wrinkles, shrink pores, tighten and enhance skin tissue, or treat acne, scars, or reduce fat (fat softening or decomposition), etc.”.
For example, products intended to “fading wrinkles (such as forehead lines, crow’s feet, etc.), reducing fine lines, removing wrinkles around the eyes, improving sagging, lifting apple muscles, lifting facial contours, tightening contours, tightening skin, sculpting and shrinking pores” should be regulated as Class III medical devices.
c)If the RF therapy devices or RF skin therapy devices have extra functions (such as microcurrent stimulation, ultrasound therapy, intense pulsed light therapy, cold compress, etc.), they shall be regulated as Class III devices.
For example, a product with two working mechanisms: radiofrequency skin treatment and intense pulsed light hair removal, the classification and regulation shall be determined according to the most stringent classification. It shall be determined as Class III device.
3. RF products that do not meet the definition of medical devices are not regulated as medical devices, such as RF devices intended to enhance non-invasive skin osmosis of essence, enhance essence absorption, skin cleansing, warm massage, physical massage, relaxes and exfoliates skin, etc.