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Industry InsightLatest NewsMarketingRegulations24/05/2021Radio Frequency Beauty Products will be regulated as Class II/III Medical Device

Radio Frequency

4月16日,中国食品药品监督管理研究院发布了“射频美容产品分类办法”(以下简称“原则”),可用于规范医疗器械领域射频美容产品的分类和定义,并为行业和监管部门提供注册批准技术指导。

According to the principle, it stipulates that not only the large-scale Radio Frequency (RF) beauty equipment used by beauty institutions but also household RF beauty instruments are very likely to be included in the scope of medical device supervision.

In this case, massive RF beauty products that are currently sold in the China market could be necessary to do medical device compliance in the future.

Radio Frequency Beauty Products will be regulated as medical devices.

In accordance with the principles, RF beauty products that meet the following attributes will be managed as medical devices. Based on the level of product risk, the management category should not be lower than Class II. Specific attributes defining as follows:

  1. Products that are intended to use of RF energy act on the human body (including but not limited to skin and subcutaneous tissue deep soft tissue), to achieve Local superficial gentle heating, improve blood circulation and other purposes;
  2. The second type is the product that expected to use RF energy to act on the human body (including but not limited to skin tissue and deep subcutaneous soft tissue, etc.), causing pathological/physiological changes in human tissues and cells, and may cause potential impact or damage to the human body (such as edema, Erythema, scalds, micro scars, subcutaneous fat necrosis collapse and other clinical diseases).
  3. The third type is the product directly used on (including but not limited to) lipolysis, shaping, scar treatment, obvious changes in skin texture and other clear medicine treatment behavior and may cause potential impact or damage to the human body (such as immediate tissue contraction response, tissue degeneration, cell apoptosis, etc.).

According to the definition made by the principles above, CosmeticsBridge found that the currently best-selling home radio frequency beauty devices on the market are similar to the first type of RF products. The home RF beauty device mainly uses RF energy to directly act on the dermis to heat the collagen fibers and shrink the collagen fibers, so as to achieve the effect of lifting and tightening and improving fine lines.

This means that the household Radio Frequency beauty devices will be definitely managed as medical devices.

High-end beauty Device business in China will Be Reshuffled.

The scale of China’s beauty devices market in 2019 was 6.62 billion RMB, with an output of 6.794 million units, a year-on-year increase of 21.82%, and it has become a major increasing market in the beauty field in recent years. Specific to the radio frequency beauty devices, it is a typical representative of the high-end beauty devices market, and the price is often more than 1,000 RMB. Most of the famous overseas beauty equipment brands almost all launched radio frequency beauty equipment in China.

This year, the newly revised “Regulations on the Supervision and Administration of Medical Devices” also used the concepts of registrant and filing person as cosmetics to strengthen the main responsibility of enterprises, optimize the approval filing procedures, encourage innovation, and increase penalties for illegal acts.

According to the regulation, Class I of medical devices with lower risk is required to do the notification/filing. But Class II and Class III types of medical devices are all necessary to do the registration and obtain a marketing permit before they can be put into the markets. And the registration will consume huge extra time and cost investment of the brands.

As a result, if radio frequency beauty products are included in the management of medical devices, it will not only affect the home radio frequency beauty devices market, but may also set off a storm in the entire high-end beauty devices market.

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