Hot Topic: Beauty Devices Regulated As Medical Devices - A Trend to Continue

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 devices. 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 equipmentSecond Level Product Category:Laser treatment equipmentRisk 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 deviceRisk 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 equipmentSecond Level Product Category:Photodynamic laser treatment equipmentExample(s):Frequency doubling Nd: YV04 laser photodynamic therapy instrument,
HeNe laser photodynamic therapy instrument, semiconductor laser photodynamic therapy machine, laser dynamic therapy systemRisk Class:II & III

First Level Product Category:Light therapy equipmentSecond Level Product Category:Photodynamic therapy equipmentExample(s):Photodynamic therapy instrumentRisk Class:III

First Level Product Category:Light therapy equipmentSecond Level Product Category:Strong Pulsed Light Therapy EquipmentExample(s):Intense Pulsed Light Therapy ApparatusRisk Class II:II

First Level Product Category:Light therapy equipmentSecond Level Product Category:Red light treatment equipmentExample(s):Red light therapy device,
magneto-rotation photon hyperthermia deviceRisk Class:II

First Level Product Category:Light therapy equipmentSecond Level Product Category:Blue light treatment equipmentExample(s):Blue light therapy deviceRisk Class:II

First Level Product Category:Light therapy equipmentSecond Level Product Category:UV treatment equipmentExample(s):Ultraviolet treatment deviceRisk Class:II

Radio-frequency (RF) equipment

First Level Product Category:High-frequency treatment equipmentSecond Level Product Category:Radio frequency superficial treatment equipmentExample(s):High-frequency electric field skin heat treatment instrumentRisk Class:II

Ultrasound treatment equipment

First Level Product Category:Ultrasound treatment equipment and accessoriesSecond Level Product Category:Ultrasound treatment equipmentExample(s):Ultrasound therapy system,
ultrasound therapy device,
all-digital ultrasound therapy device,
electrotherapy ultrasound therapy device,
ultrasound physiotherapyRisk Class:II

Other devices emitting electric pulses or sound waves

First Level Product Category:High-frequency treatment equipmentSecond Level Product Category:Microwave treatment equipmentExample(s):Microwave hyperthermia machine,
microwave auxiliary treatment system,
microwave treatment instrumentRisk Class:III

First Level Product Category:High-frequency treatment equipmentSecond Level Product Category:Shortwave therapeutic apparatusExample(s):Shortwave therapeutic apparatus,
ultrashortwave electrotherapy machineRisk Class:II

First Level Product Category:High-frequency treatment equipmentSecond Level Product Category:Millimeter wave treatment equipmentExample(s):Millimeter wave treatment equipmentRisk Class:II

Mechanical suction

First Level Product Category:Force Therapy Equipment/ApparatusSecond Level Product Category:Negative pressure (vibration) treatment equipmentExample(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.