Certified RF Beauty Devices Hit Shelves, Stirring Up Billion-Dollar Market?
The radiofrequency (RF) beauty device industry, which has experienced more than half a year of turmoil due to policy changes, is facing a new situation. The first batch of home-use RF beauty devices that are "licensed to operate" are expected to be on the shelves before the "Double 11" shopping festival, which will also initiate a new round of competition.
Trends Become Clear Amidst "Chaos"
On October 15th, Shenzhen Yushi Technology Co., Ltd. (hereinafter referred to as "Yushi Technology"), under its brand MARY FAIRY, officially obtained the first Class III medical device production license, becoming the first brand to receive both the registration certificate and production permit. As the "Double 11" promotion begins, products that have already started "licensed operation" preheating on e-commerce platforms are scheduled to be officially launched this week.
However, when First Financial Daily reporters checked major e-commerce platforms, they found that a large number of RF beauty device brands that have not yet obtained the Class III medical device production license almost overshadowed the heat of the first batch of "licensed operation". Against the backdrop of policy changes, home-use RF devices are back in a state of "chaos".
According to the "Announcement on Adjusting Some Contents" (No. 30 of 2022) issued by the National Medical Products Administration in March 2022, starting from April 1, 2024, RF treatment devices and RF skin treatment devices will not be allowed to be produced, imported, and sold without obtaining a medical device registration certificate in accordance with the law.
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However, after a two-year transition period, the "Announcement on Further Clarifying the Relevant Requirements for RF Treatment Device Products" issued by the National Medical Products Administration in July this year clearly stated that the effective date of the new regulations has been postponed to April 1, 2026. This means that the home-use RF beauty device industry has started another two-year "buffer period", which also reduces the advantage of the brands that have taken the lead in obtaining the double certificates.
Nevertheless, the future development direction of the industry has become clear.
"The difficulty of applying for a Class III medical device certificate is still very high, and it is a great test for the brand's R&D capabilities, management capabilities, and financial strength," said Huang Yanning, the operations director of Yushi Technology, to First Financial Daily. Although affected by the new buffer period, the current advantage of obtaining double certificates first has been somewhat reduced. However, the certification cycle is long, and it is estimated that only a few companies will be able to obtain certificates this year. The trend of the industry moving from "marketing-driven" to "R&D and product power-driven" is clear. Certified products will also gain long-term competitiveness and drive the recovery of this niche market from the trough.
In addition to MARY FAIRY, the first batch of brands to "get the certificate" also includes AMIRO, under the Zongjiang Technology. The brand has also hung a banner of "the first batch of certified nationwide" in the live broadcast room.
Before the introduction of the new regulations, the home-use RF beauty device market, which was regulated by the "small appliance" industry standards, was not short of chaos, with safety risks such as electric leakage, poor contact, excessive heavy metals, and skin burns for users occurring from time to time. Under strong supervision, the leap from the original "small appliance" to obtaining a Class III medical device license is not easy for most beauty device companies. From clinical trials to registration and market launch, it not only takes a long time but also costs a lot. Industry insiders say that most domestic beauty device manufacturers are not large in scale and it is difficult to bear the cost of "getting the certificate".The registration certificate for Class III medical devices is specifically designed for the registration and supervision of high-risk medical devices. It requires full lifecycle regulation of various aspects such as product design, materials, manufacturing, sterilization, packaging, storage, transportation, distribution, and use. Scientific and rational methods are employed to analyze and evaluate clinical data to confirm the safety and effectiveness of medical devices within their intended use. Due to the extremely high difficulty and complexity of obtaining this certification, although several brands claimed to have entered the final review stage earlier this year, it was not until October that the first batch of brands announced they had received the certification.
As one of the first batch of certified brands, Mary Fairy's application took two and a half years. Gao Xiang, the R&D director of Yushi Technology Mary Fairy, told Yicai that besides continuous investment in research and development, another key factor was their investment in establishing their own factory in 2022. "This way, from research and development to production and after-sales service, effective regulation throughout the product's lifecycle can be achieved."
How much will the market recover?
In an economic downturn, the trend of consumer differentiation becomes more apparent. Under the new two-year grace period, the recovery of home radiofrequency beauty devices also faces significant uncertainty. In addition to a large number of beauty device brands that have not yet obtained certification rushing to ship goods during the grace period, the transformation and market reshaping of this billion-dollar industry require investment and patience.
Huang Yantin admitted that, affected by the new regulations, the beauty device industry experienced a significant drop in prices since the beginning of this year. Even though the transition period was extended in July, there was no significant rebound in sales volume in the entire market. After the industry went through turbulence, consumers are more inclined to wait and see, maintaining a more rational attitude.
"The overall sales data is not very good," according to feedback from a leading domestic e-commerce platform. From the high heat to the current cooling down, the online sales volume of home radiofrequency beauty devices has not significantly rebounded. The sales volume from "Double 11" to the end of the year also needs to be observed.
Tianyancha data shows that as of October 2024, there are more than 26,000 existing enterprises related to "beauty devices". From January to October 2024, nearly 200 new related enterprises were added, a 57% decrease compared to the same period in 2023. In terms of regional distribution, Guangdong, Shandong, and Jiangsu have the top three numbers of related enterprises.
The domestic radiofrequency beauty device market was initially mainly imported from foreign brands. With the cultivation and growth of the market, home handheld applications have emerged, providing new business opportunities for China's small appliance manufacturing. Under the clear trend of strong regulation of the new regulations, these Chinese brands that have developed from the local market are on the one hand, replacing or strengthening competition with foreign brands in the adjustment of the new regulations, and on the other hand, they are actively planning to "go out" in the internal competition.
"Our next sales plan is to shift from focusing on online to expanding channels offline, and then try to enter the overseas market," Huang Yantin proposed, "(After the new regulations) the domestic requirements for radiofrequency beauty devices are stricter than overseas. Directly included in domestic Class III medical devices, it is equivalent to the safety level of cardiac pacemakers, which belongs to high-difficulty regulatory requirements. This indicates that our products are already in a relatively leading position compared to foreign products, so there should not be too much difficulty in obtaining permits in the overseas market next."
Regarding whether home radiofrequency devices are a tax on intelligence, Li Yonglin, the director of the plastic surgery department of the First People's Hospital of Zhengzhou City, explained to Yicai: Radiofrequency skin treatment devices, from a medical perspective, work because radiofrequency energy can penetrate the epidermis and act on the dermis, thereby using the micro-thermal effect to promote the regeneration of collagen in the dermis, and thus producing local anti-aging clinical effects such as reducing wrinkles. This principle is reliable in clinical practice and is relatively safe. As for the existing home radiofrequency devices on the market, clinical doctors were not sure about their efficacy before the new regulations were introduced. After the new regulations were implemented, certified products at least have safety guarantees. With the popularization of home radiofrequency devices, the entire market, including medical aesthetics, will achieve faster growth.