On April 16, 2021, the NIFDC (National Institute for Food and Drug Control) issued the technical guidelines (draft) for the product classification of radio frequency beauty products. Although there is still no separate category of beauty devices in the NMPA classification catalogue, the following popular beauty devices are classified as medical devices according to the classification catalogue in China:
- Laser hair removal products
- Intense pulsed light treatment equipment
- LED phototherapy equipment
- Red light treatment equipment
- Blue light treatment equipment
- Ultraviolet treatment equipment
- Ultrasound treatment equipment
- Plasma treatment equipment
These equipment are mainly intended for hair removal, wrinkle treatment, skin treatment, acne treatment, etc. Cisema highly recommends manufacturers of beauty devices to start looking for the most appropriate route to NMPA approval in China.
Cisema can provide a full range of services for the NMPA registration of beauty devices and to comply with the necessary Chinese standards. The following table lists out the medical device classification information, which are also applicable for various types of beauty devices and can be found under product categories, such as physiotherapy equipment.
Light therapy equipment
| First Level Product Category: | Light therapy equipment |
| Second Level Product Category: | Laser treatment equipment |
| Risk Class III Example(s): | Excimer laser skin treatment machine, ruby laser treatment device, semiconductor laser treatment device, semiconductor laser hair removal machine, dye laser treatment device, alexandrite laser treatment device, long pulse Nd:YAG laser treatment device, Nd:YAG laser treatment device, Nd : YAG laser hair removal machine, skin laser treatment device, erbium-doped fiber laser treatment device |
| Risk Class II Example(s): | He-Ne laser therapy machine, He-Ne laser/LED therapy device, semiconductor laser therapy device, semiconductor laser/low frequency therapy device |
| First Level Product Category: | Light therapy equipment |
| Second Level Product Category: | Photodynamic laser treatment equipment |
| Example(s): | Frequency doubling Nd: YV04 laser photodynamic therapy instrument, HeNe laser photodynamic therapy instrument, semiconductor laser photodynamic therapy machine, laser dynamic therapy system |
| Risk Class: | II & III |
| First Level Product Category: | Light therapy equipment |
| Second Level Product Category: | Photodynamic therapy equipment |
| Example(s): | Photodynamic therapy instrument |
| Risk Class: | III |
| First Level Product Category: | Light therapy equipment |
| Second Level Product Category: | Strong Pulsed Light Therapy Equipment |
| Example(s): | Intense Pulsed Light Therapy Apparatus |
| Risk Class II: | II |
| First Level Product Category: | Light therapy equipment |
| Second Level Product Category: | Red light treatment equipment |
| Example(s): | Red light therapy device, magneto-rotation photon hyperthermia device |
| Risk Class: | II |
| First Level Product Category: | Light therapy equipment |
| Second Level Product Category: | Blue light treatment equipment |
| Example(s): | Blue light therapy device |
| Risk Class: | II |
| First Level Product Category: | Light therapy equipment |
| Second Level Product Category: | UV treatment equipment |
| Example(s): | Ultraviolet treatment device |
| Risk Class: | II |
Radio-frequency (RF) equipment
| First Level Product Category: | High-frequency treatment equipment |
| Second Level Product Category: | Radio frequency superficial treatment equipment |
| Example(s): | High-frequency electric field skin heat treatment instrument |
| Risk Class: | II |
Ultrasound treatment equipment
| First Level Product Category: | Ultrasound treatment equipment and accessories |
| Second Level Product Category: | Ultrasound treatment equipment |
| Example(s): | Ultrasound therapy system, ultrasound therapy device, all-digital ultrasound therapy device, electrotherapy ultrasound therapy device, ultrasound physiotherapy |
| Risk Class: | II |
Other devices emitting electric pulses or sound waves
| First Level Product Category: | High-frequency treatment equipment |
| Second Level Product Category: | Microwave treatment equipment |
| Example(s): | Microwave hyperthermia machine, microwave auxiliary treatment system, microwave treatment instrument |
| Risk Class: | III |
| First Level Product Category: | High-frequency treatment equipment |
| Second Level Product Category: | Shortwave therapeutic apparatus |
| Example(s): | Shortwave therapeutic apparatus, ultrashortwave electrotherapy machine |
| Risk Class: | II |
| First Level Product Category: | High-frequency treatment equipment |
| Second Level Product Category: | Millimeter wave treatment equipment |
| Example(s): | Millimeter wave treatment equipment |
| Risk Class: | II |
Mechanical suction
| First Level Product Category: | Force Therapy Equipment/Apparatus |
| Second Level Product Category: | Negative pressure (vibration) treatment equipment |
| Example(s): | Negative pressure suction physical therapy instrument, vibration physical therapy instrument, etc. |
| Risk Class: | II |
By Anton Yao, Colleen Xu and Jacky Li. Contact Cisema if you would like to learn more.
