Beauty instrument may usher in the era of strong supervision

202105-17

recently，The Medical Device Standards Management Center of the State Drug Administration issued a request for the "Guiding Principles for the Classification and Definition of Radio Frequency Beauty Products"(Draft for comments)(Hereinafter referred to as "Draft for Solicitation of Comments")"Notice of opinion，Which stipulates，Not only the large-scale RF beauty equipment used by beauty institutions，The current hot home radio frequency beauty instrument may also be included in the scope of medical device supervision。

Radio frequency beauty products may be included in medical device supervision

The "Draft for Comments" pointed out，Define the attributes of RF beauty products according to the guiding principles，RF beauty products that meet the following attributes，It will be managed in accordance with medical devices. The specific attributes are defined as follows：

(One)Expected to use radio frequency energy to act on the human body(Including but not limited to skin tissue and deep subcutaneous soft tissue, etc.)，Achieve local superficial mild heating、RF beauty products for improving blood circulation and other purposes;

(two)Expected to use radio frequency energy to act on the human body(Including but not limited to skin tissue and deep subcutaneous soft tissue, etc.)，Make human tissue、Pathological/physiological changes in cells，And may cause potential impact or damage to the human body(Such as edema、erythema、scald、Micro scar、Clinical symptoms such as subcutaneous fat necrosis and collapse)RF beauty products;

(three)Used directly(including but not limited to)Lipolysis、Shaping、Scar treatment、Clearly change skin texture and other clear medical treatment behaviors，And may cause potential impact or damage to the human body(Immediate tissue contraction、Tissue degeneration、Apoptosis etc.)RF beauty products。

Definitions based on the guiding principles，Reporter found，Chupu、Ya Meng、Refa、Matsushita、Silk’n and many other home radio frequency beauty instrument advertisements claim that radio frequency energy penetrates into the dermis to warm and tighten the skin. The principle is similar to the first case.。

To this，Insiders told reporters，Launch of "Draft for Comment"，It means that it is not only the large-scale RF beauty equipment used by beauty institutions，The current hot home radio frequency beauty instrument may also be included in the scope of medical device supervision。

Chaos in the beauty instrument industry

Bring goods in the anchor、Celebrity endorsements、Social media planting grass and other promotion，Beauty instrument has gradually become a new fashion in skin care。Widely sought after by consumers。According to the latest data from Zhiyan Consulting，2021The annual beauty instrument market will be close to 10 billion yuan，Will exceed 20 billion U.S. dollars by 2026。The online sales of home beauty equipment increased from 10 million in 15 to 70 million in 19，Increased nearly 7 times in four years

However, behind the barbaric growth，But it reveals the lack of supervision。for a long time，Security in doubt、Beauty instruments of substandard quality are often criticized by consumers。

2020In August 2008, the 10 hot-selling household beauty products released by the Shenzhen Consumer Council are in a comparative experiment，There are 6 models with high nickel release，Easy to cause skin allergies;Two beauty devices do not meet the standard，Risk of low temperature burns。In addition，The 5 tested models claim to have instant lift、Secondary cleaning、The beauty devices with heat-introduction effects in the past two years are not as effective as those promoted by the merchants.。

In addition，In the case of Wang Hai’s anti-counterfeiting Mujin Beauty Apparatus，The beauty instrument brand claims that it has obtained the US FDA certification，Actually，This statement was verified as false propaganda。same，These dazzling various international certifications cannot provide effective proof of product safety and efficacy.，It's just a way for the brand to use the information gap to deceive and mislead consumers。

Industry：The market urgently needs a unified standard

As a substitute for medical beauty，In recent years, home beauty equipment has entered a rising period of development，The categories are getting more and more abundant，Cleansing instrument、Face steamer、Radio frequency instrument、Eye-beautifying devices are emerging in endlessly。but，Due to lack of standard specifications，Home beauty equipment has long been wandering in the gray area of ??supervision，product quality、Issues such as efficacy have also been criticized。

The reporter learned，At present, most household beauty instruments in my country are managed according to household small appliances，Relevant definitions and standards are relatively general and vague，There are no special mandatory testing requirements in terms of product safety。

"The country and the industry have、There is currently no uniform standard for temperature control devices。As it is not in the scope of medical device management，The effect of the beauty instrument does not require clinical verification，Therefore, some companies falsely promote the concept of hype during sales.。"Before，Lai Wei, director of the Dermatology Department of the Third Affiliated Hospital of Sun Yat-sen University, publicly stated，There have been no relevant standards for the beauty effect of home beauty instruments in my country，Facing market chaos，The difficulty of supervision is self-evident。

The relevant person in charge of Chupu told reporters，The chaos of "Principles" in regulating the medical aesthetics market，Is definitely the right direction。"While corporate self-discipline，Appeal to regulators，Introduce a corresponding system，Prohibit exaggerated publicity，Safeguard consumer interests。“、The person in charge emphasized，CFDA has very high experience and professionalism in medical equipment，There are also very rigorous standards for medical definition standards。Considering that the current development of radio frequency is not only medical beauty，There are also life beauty and home beauty，So this standard should take into account the latest status quo of the current development of radio frequency，And can’t simply follow the previous medical equipment across the board。

"Although the home beauty instrument is a beauty product，But it is not in the scope of supervision of cosmetics-related associations and management departments." Du Hong, secretary general of Guangdong Cosmetics Quality Management Association, told reporters，Beauty instruments belong to two categories: electronic products or medical devices，It depends on what kind of standards it implements.，

Now the guidelines are published，Radio frequency beauty instrument as a medical device for management，Undoubtedly lay the foundation for the healthy development of the entire beauty instrument market。