In April, the radio frequency (RF) beauty devices are about to face the deadline for policy regulation. Meanwhile, the RF beauty device market is still plagued by negative public opinion such as “brand disappearances,” price drops, and “stupid tax.”
This also signifies that the RF beauty device industry has reached a critical historical juncture. On the one hand, a group of leading beauty device brands are racing against time to complete the registration process for three types of medical devices. On the other hand, there is also a wave of brands and companies choosing to switch tracks and seek alternative paths.
So, amidst the upcoming major changes, what is the current situation of the RF beauty device market? What new opportunities will the future beauty device market development bring?
The deadline is approaching, and no company has obtained certification
In recent years, the beauty device industry has experienced rapid growth. According to data from the “2023 China Cosmetics Yearbook” published by CHAILEEDO, the Chinese beauty device market was approximately 18.37 billion yuan in 2023, with a year-on-year growth of 70%, and a market share increase of 0.9 percentage points to 1.4%.
Behind the blind rush, home-use radio frequency (RF) beauty devices are about to enter the era of medical device regulation. According to the “Guiding Principles for Registration Examination of RF Beauty Devices” published by the Medical Device Technical Evaluation Center of the National Medical Products Administration, “Starting from April 1st this year, RF beauty devices will be officially classified as Class III medical devices. It is explicitly stated that RF treatment devices and RF skin treatment devices cannot be produced, imported, or sold without obtaining medical device registration certificates in accordance with the law.”
According to a survey by CHAILEEDO, even before the National Medical Products Administration issued the relevant regulations, many beauty device brands had started the registration process for Class III medical devices. However, to date, no company has publicly announced that they have completed the registration. The responsible person of a beauty device ODM/OEM company also told CHAILEEDO, “To my knowledge, many companies are applying for Class III medical device registration certificates, but I have not heard of any company that has successfully obtained the certificate.”
So, which beauty device-related companies have the highest chance of obtaining certification?
According to CHAILEEDO’s search on the Ministry of Science and Technology’s government service platform, since 2023, the platform has issued 24 announcements on the registration status of international cooperation clinical trials for human genetic resources in China. Among them, there are only four projects related to beauty devices, involving brands such as Flossom, YA-MAN, OGP, and AMIRO, with registration dates in March and April of last year.
Regarding this, the official customer service of the OGP flagship store on Tmall told CHAILEEDO, “In April, the store will temporarily remove RF devices, and it is expected to successfully obtain Class III medical device registration qualifications by the end of the year and then relist the products.” The official customer service of the YA-MAN flagship store on Tmall stated, “The certification application work is currently progressing steadily.” Shen Xun, Chief Product Officer of Flossom, openly admitted in an interview, “Before obtaining the certificate, there will be several months during which RF devices cannot be sold.” The official customer service of the AMIRO flagship store on Tmall also stated, “AMIRO is one of the first companies in China to register home-use RF beauty devices as Class III medical devices and is expected to be among the first certified companies in the industry.”
In addition to the four companies mentioned above that have obtained registration numbers, many other brands have claimed to be actively pursuing registration and filing. For example, the domestic beauty device brand Maryshine publicly stated in July of last year that it was “one of the first home-use beauty device brands to conduct multicenter clinical trials for RF beauty devices.” In the response statement regarding rumors of “disappearing” brands, Chupu also mentioned, “The brand’s relevant work on registering Class III medical devices is currently progressing steadily.”
At the same time, many brands have not provided a positive response regarding the progress of Class III medical device registration. Customer service of a well-known beauty device brand flagship store told CHAILEEDO, “The products currently sold in the store comply with relevant national standards and have passed safety certifications. They can be sold normally during the transition period.” Some beauty device brands also stated, “The specific situation is still unclear. It is recommended to wait until April.”
It is clear that for brands hoping to seize the RF device market, the only option currently is to obtain Class III medical device registration certificates.
Why is it difficult to obtain Class III medical device registration certificates?
Although many brands have started the registration process, no company has obtained a Class III medical device registration certificate so far. The registration process for medical devices is complex. Companies need to prepare various materials, including inspection reports and clinical evaluation data, during the preparation stage of the registration application. Once the application is submitted, it may go through processes such as supplementary submissions and expert evaluations, which can be time-consuming and costly.
Shen Xun, in an interview, openly stated that from the perspective of companies, completing the application requires hardware updates, pre-experiments, clinical observations, subject recruitment, application filing, supplementary submissions, and many other processes. Flossom, for example, has formed a team of over 20 people and spent over 10 million yuan on the application.
In addition, manufacturers of beauty devices have informed CHAILEEDO that to meet the requirements of Class III medical devices, the current products need to be redesigned, undergo inspections, and undergo clinical trials. They also need to find factories that meet the production requirements of Class III medical devices. Under normal circumstances, completing the entire process takes about 20 months. It requires an investment of at least 2 million yuan, and if the clinical certification is not successful, repeated experiments may be necessary.
An anonymous source from a beauty device manufacturing company informed CHAILEEDO that although they were among the first companies to start the application, it is still unknown whether they will be able to successfully obtain the registration certificate. They cannot provide a specific time for obtaining the certificate and can only wait for the approval process by the authorities. If strictly following national policies, RF products can only be launched after obtaining the certificate.
In other words, the challenges of obtaining Class III medical device registration certificates include high research and development costs, which typically start at millions or tens of millions of yuan. The approval process is lengthy and difficult, with clinical trials potentially taking 18-36 months or more and requiring repeated validations. Market sales channels and marketing promotions are also restricted, as operating units need to obtain Class III medical device operation permits and may not use celebrity endorsements, among other limitations. Therefore, many companies are prepared to face several months or even longer periods during which RF devices cannot be launched.
During CHAILEEDO’s market research, several beauty device companies expressed that due to the lack of successful certificate recipients, there might be a possibility of policy extension. The responsible person of the aforementioned beauty device ODM/OEM company informed CHAILEEDO that they have heard news of a possible two-year extension. A beauty device manufacturer in Guangdong also stated that there are rumors of a possible delay until 2025, but they haven’t seen any official documents. Whether to continue stocking RF products now depends on individual judgment. According to the manufacturer, the current RF product inventory is still significant.
Regarding the possible policy extension, CHAILEEDO recently contacted the National Medical Products Administration and left inquiries on the official website of the State Administration for Market Regulation. However, as of the time of writing, no response has been received.
The beauty device market is undergoing a “major reshuffling”
Certainly, regardless of whether there will be changes in policies, radiofrequency (RF) beauty devices will be included in the regulation of medical devices, which has become an established fact. It is precisely due to the approaching deadline of the policy that RF beauty device products have experienced significant price drops since last year.
According to the head of a leading beauty device brand, for distributors, it is indeed necessary to sell products before April of this year; otherwise, the products will accumulate completely. “Currently, many distributors have already sold products at the cost of hardware. Brands also need to consider pricing their products reasonably based on competitive pricing,” said the responsible person.
Currently, on platforms such as Douyin (Chinese version of TikTok), the top-selling beauty devices are mostly priced at around a hundred yuan, and beauty devices priced above 2,000 yuan are almost non-existent. An online distributor of beauty devices candidly told CHAILEEDO, “After April, it is indeed impossible to sell according to regulations, so RF products are currently being sold at clearance prices.” There are also many complaints about price reductions for beauty devices on the Black Cat Complaints platform, with most complainants demanding that the brands refund the price difference after the significant price drop.
Secretary-General Su Jing of the Center for Global Development and Health Communication at Tsinghua University publicly stated, “The policy of regulating RF beauty device equipment as Class III medical devices is a very correct starting point and direction. However, if after the policy is implemented, only a few companies can complete the application and obtain Class III medical device qualification certificates, it may have a significant impact on the entire industry.”
In essence, the discussions about price drops and brands exiting the market have clearly affected the sales of beauty device products. According to CHAILEEDO’s intelligence data, among the top 20 brands in the beauty device category on Douyin in February, nine brands showed a negative growth trend in GMV (Gross Merchandise Volume), and five brands had almost zero growth, with only six brands showing positive growth.
Of course, RF beauty devices are just one branch of beauty devices. Currently, popular home beauty devices include RF, microcurrent, import/export, laser, and LED devices, among others. Other categories are also new avenues that companies can explore. In fact, many leading beauty device companies have already started to develop new products, attempting to fill the market gap left by RF beauty devices with their new offerings. Previously, CHAILEEDO conducted a survey on new beauty device products in 2023, and apart from RF products, nearly 70% of new products were LED beauty devices and microcurrent beauty devices.
It is worth mentioning that recently, unipolar RF product manufacturer YOUMAGIC’s research and development company, Weimai Qingtong Medical Technology (Wuxi) Co., Ltd., announced the completion of nearly 100 million yuan in Series A financing, led by DHBF (Dinghui Bohui Fund), with participation from Chuangjian Medical and additional investment from Betanni Group. This indicates that professional RF products have become a new direction for industry investment.
Overall, the beauty device market has long passed the stage of early and rapid growth, and it is inevitable that policies will tighten and the market landscape will quietly change. As for the current RF beauty device market, on the one hand, being the first to obtain a “license” undoubtedly means having the “first-mover advantage” and being able to quickly seize market opportunities. On the other hand, further exploring the space for non-RF products is also the key for beauty device companies to gain an advantage in the industry reshuffling. It can also be seen that in order to establish a foothold in the beauty device market in the future, relying on technological and product strength is the way to take the lead.
