In recent years, the rapid development of at-home beauty devices has been evident in China. Public data shows that Chinese domestic beauty device brands were once again the biggest winners during this year’s Chinese Double 11 Shopping Festival, with impressive sales figures.
However, with only four months left until radiofrequency (RF) beauty devices are included in the management of Class III medical devices, many practitioners in the beauty device industry believe that the resulting losses will be immeasurable, and non-certified products will have to be abandoned.
On one hand, the beauty device market is flourishing, but on the other hand, the implementation of the requirement for RF beauty devices to be certified is approaching, which will create a period of transition. Just before Singles’ Day, several leading beauty device brands launched new products such as large LED face masks and beauty device face masks, creating new opportunities in the market.
Is RF cooling down? New favorites for beauty device brands
It has been observed that many top Chinese domestic and international beauty device brands have expanded their product lines this year, introducing LED beauty devices and microcurrent beauty devices, among others.
For example, just before Chinese Double 11 Shopping Festival, Ulike, a brand under Hangzhou Ulike Technology Co., Ltd., which has been focused on the field of hair removal devices, launched the new LED face mask. At the same time, another brand under the same company, Jmoon, also introduced an LED beauty device with a large face mask. Another leading beauty device brand, Ya-men, has launched two microcurrent beauty devices this year.
From a technological and theoretical perspective, home beauty devices can be divided into five main categories: LED beauty devices, import/export beauty devices, microcurrent beauty devices, laser beauty devices, and RF beauty devices.
Among all home beauty devices, LED beauty devices have been leading the market with extremely high growth rates, making them the undeniable dark horse of the beauty device industry in the first half of the year. Data from Tmall’s New Product Innovation Center shows that from August 2022 to July 2023, LED beauty devices had the highest growth rate among home beauty devices on Tmall and Taobao, with a growth rate exceeding 1619%, while RF beauty devices and import/export beauty devices grew by 55% and 27% respectively.
“LED face masks have been popular this year, and all related products have been selling like hotcakes,” said Liu Jie, a representative of a Shenzhen-based company specializing in RF beauty device solutions. The RF beauty device market has already developed to a certain extent, and LED beauty devices are the result of market education. Consumers have recognized the effectiveness of LED photon skin rejuvenation, leading to rapid market growth this year.
Wang Hua, from Shenzhen-based ODM/OEM beauty device company, also stated that LED beauty devices have a lower technological threshold and are relatively easier to develop compared to other products. Additionally, with the strong promotion of LED face masks by many leading brands, the market and consumers have also shown greater acceptance of this type of beauty device.
Apart from market factors, policy considerations are undoubtedly important as well. It is understood that in April of last year, the National Medical Products Administration issued the “Guiding Principles for Registration Review of RF Beauty Devices,” which classified RF beauty devices as Class III medical devices. It was stipulated that from April 1, 2024, RF treatment devices and RF skin treatment devices must obtain medical device registration certificates in order to be produced, imported, and sold legally.
In other words, in just four months, the home RF beauty device sector will enter a new era of development under strict registration management. The entire beauty device market will bid farewell to “wild growth” and once again prioritize safety.
Wang Hua further stated, “The inclusion of RF beauty devices in Class III medical devices for strict registration management means that RF beauty device brands without qualifications must change their product lines.”
Even though many beauty device brands have already begun preparations, it will be difficult to obtain registration certificates before April next year. Some brands optimistically estimate that they may only obtain the Class III approval by the end of 2024. This means that there will be a period of transition in the RF device market, and brands will have to expand their product lines to fill the gap and maintain their market share.
“Licensed Employment” requires millions of demand
According to publicly available data, the market size of domestic beauty devices in China was approximately 11.54 billion yuan in 2022, and it is expected to reach 13.52 billion yuan ($ 1.89 billion) in 2023. Combined with the data from the Chinese Double 11 Shopping Festival, the market’s booming level is evident. During this year’s the Chinese Double 11 Shopping Festival, the GMV (Gross Merchandise Volume) of beauty devices on Douyin (TikTok) increased by 37% compared to the previous year, and 50% of the top 10 brands were domestic Chinese brands.
However, behind the strong sales, the at-home beauty device market has been plagued by false advertising and recurring quality issues.
According to a survey on beauty devices conducted by Nanfangdushibao, 45.54% of respondents stated that they had encountered safety issues while using beauty devices. Among them, 16.12%, 15.28%, and 12.45% of the respondents had experienced problems such as excessive heavy metals, electric leakage, poor contact, and skin burns. On social media and platforms like “Black Cat Complaints,” there have also been numerous doubts and complaints regarding after-sales service, exaggerated advertising, and beauty device products.
“In the past few years, there have been too many medical accidents involving home beauty devices in the market,” said Wang Hua. RF (Radiofrequency) beauty devices were previously large-scale equipment used in beauty salons, but after transitioning to the home beauty device consumer scene, many consumers are not familiar with their proper use, leading to problems like burns. Additionally, the core function of RF devices is wrinkle reduction, but the effectiveness varies due to factors such as age, genetics, and usage techniques. Many consumers doubt the authenticity of the products when they don’t see noticeable results, resulting in a relatively high dispute rate.
In the face of rampant issues, the national regulatory authorities have had to take urgent and high-level measures. However, objectively speaking, it is a significant challenge for RF beauty device companies to meet the requirements for Class III medical device control. It is understood that obtaining Class III medical device status is not an easy task and requires the establishment of a GMP (Good Manufacturing Practice) system, product testing, animal experiments, clinical trials, successful registration declaration, and obtaining a Class III medical device registration certificate and medical device production license. This process takes a long time and requires substantial financial investment.
According to consultations with several ODM/OEM (Original Design Manufacturer/Original Equipment Manufacturer) beauty device manufacturers and brand owners, as of now, only a few leading beauty device brands are undergoing the application process for Class III medical device registration certificates. According to the “Public Announcement of the Registration of International Cooperation Clinical Trials on Human Genetic Resources in China” released by the Ministry of Science and Technology this year, four brands and their associated companies, FLOSSOM, Ya-men, OGP, and AMIRO, have applied for clinical trials to evaluate the safety and effectiveness of RF skin treatment devices.
Liu Jie stated that for companies applying for Class III medical device qualifications, they need to have production and sales qualifications, and their products must pass the certification for Class III medical devices. In terms of overall investment, it would require at least 2 million yuan. “And there is no guarantee of success because it needs to go through clinical certification, which may require repeated experiments.”
“Our company is currently in the process of applying for Class III medical device qualifications, and it involves considerable investment,” said Wang Hua. “First, we need to redesign and produce products that comply with medical standards. Currently, our products are in the stage of inspection. After inspection, there will be clinical reviews. After the clinical reviews, on-site inspections of the factory are required, and the factory needs to meet the production requirements for Class III medical devices.” According to Wang Hua, under normal circumstances, completing the entire process takes 20 months. The company has already applied for nearly 6 months, leaving around 14 months remaining.
Wang Hua also mentioned that his company is among the first batch of companies pursuing Class III medical device qualifications, and the scrutiny from the regulatory authorities is strict. Consequently, there may be multiple revisions to the product in the later stages. However, once the application is successful, other companies that apply later only need to take the approved company’s product design and make slight modifications to the appearance, which increases their chances of approval.
Due to the lengthy application process and significant investment, it is understood that many companies are currently in a wait-and-see state.
“Obtaining a Class III medical device registration certificate is not easy, and the cost is high. Our strategy is to benchmark against successful companies,” explained Guo Jie, a representative from another beauty device company. Once a company successfully obtains the certification, others can use it as a benchmark, which can reduce costs to some extent.
The final frenzy of unlicensed products
As the implementation date of the new industry regulations approaches, news of clearance sales and significant price reductions for home beauty devices has been circulating since the end of last year.
A search for “price reduction of beauty devices” on Xiaohongshu (Little Red Book) reveals over ten topics such as “significant price reductions for beauty devices” and “major price cuts for RF beauty devices.” Many bloggers point out the high difficulty of registration for Class III medical devices, and brands are taking advantage of the grace period before stricter regulations are enforced to clear their inventory and boost sales.
Furthermore, it is worth noting that many beauty device brands offered substantial discounts during this year’s Singles’ Day shopping festival. For example, a popular domestic brand’s “steam iron beauty device” originally priced from 4,499 yuan was slashed in half to a post-coupon price starting from 1,949 yuan. Another beauty device originally priced from 6,199 yuan also saw a significant price reduction to 3,199 yuan after applying coupons.
Undoubtedly, the implementation of Class III medical device regulations for RF beauty devices will provide a first-mover advantage in the future compliant market competition for companies with strong research and development capabilities and the ability to verify efficacy. However, numerous small and medium-sized enterprises will face the possibility of exiting the market.
“This policy will have a significant impact on our small and medium-sized enterprises,” said Guo Jie. Survival of the fittest is the law of the market, and capable enterprises will eventually obtain Class III medical device certification, while those without the capabilities will exit the market. In the long run, this will be more favorable for industry development.
“Many companies will have to abandon all of their products. We have been in the home beauty device industry for over ten years, and we will have to abandon at least 3-5 RF beauty device products,” candidly stated Wang Hua. “The losses caused by this policy are immeasurable. We can only clear our stock as soon as possible and stop producing and selling these products.”
Wang Hua further explained that the government had already classified RF beauty devices as Class III medical devices in a document released two years ago. “We saw the good market prospects and decided to pursue Class III medical device certification for a smoother path ahead. Products without the necessary certifications will undoubtedly disappear from the market, and there will be fewer competitors.”
At the same time, experienced industry professionals suggest two approaches. First, they recommend modifying the frequency band of RF products, which falls between 300 kHz and 300 GHz, to a lower frequency below 300 kHz before selling them in the market.
Second, they suggest waiting for leading companies such as Yamei and Panasonic to obtain Class III medical device qualifications and then applying for sales qualifications to sell their products. Additionally, exporting products to Southeast Asian countries, which have more lenient regulations and no certification requirements, is also an option.
There is no doubt that as the industry enters the era of Class III medical devices, the market for home beauty devices will bid farewell to rampant growth and enter a new phase of “reshuffling.” This will be accompanied by a focus on industry health, compliance, and high-quality development.
