In the chaotic RF beauty device market, the ‘resurrection button’ has just been pressed again.
On July 8th, the National Medical Products Administration issued relevant notices and interpretations, clearly stating that RF treatment devices and RF skin treatment devices, starting from April 1, 2026, must have obtained medical device registration certificates in accordance with the law. Otherwise, they are not allowed to be manufactured, imported, or sold.
In other words, RF beauty devices have been given a two-year “buffer period.” In response to this, industry insiders have expressed that obtaining the Class III medical device registration certificate is too difficult. Considering the practical situation, the regulatory authorities have granted a grace period, which is a significant positive development for RF beauty device companies.
So, what impact will this policy adjustment have on the beauty device market? How do major beauty device brands view this change?
The implementation of the new regulations for RF beauty devices has been delayed by two years.
As widely known, on March 30, 2022, the National Medical Products Administration issued an announcement (referred to as ‘Announcement No. 30’) regarding the adjustment of certain contents in the ‘Classification Catalog of Medical Devices.’ Starting from April 1 of this year, RF treatment devices and RF skin treatment devices were officially categorized as Class III medical devices, and it was stated that they cannot be manufactured, imported, or sold without obtaining the medical device registration certificate in accordance with the law.
However, the normal registration process for Class III medical devices takes nearly two years, including clinical records, completion of trials, submission of registration applications, and acceptance of certificates. The investment involved starts from millions of dollars, posing significant challenges and pressures for related companies. As a result, many brands have chosen to withdraw from the RF beauty device market.
Today, the official website of the National Medical Products Administration published Announcement No. 84 of 2024 and related interpretations regarding further clarification of requirements for RF treatment devices. The administration stated that at this stage, the majority of applicants for handheld RF treatment devices and RF skin treatment devices are home appliance companies. Due to multiple factors such as the pandemic and the implementation of relevant standards, the product inspection and clinical trial time has been extended. Furthermore, the preparation of product registration applications and supplementary documentation requires additional time. Therefore, considering the actual product research and development, as well as the need to balance public device safety and orderly industrial development, the administration issued the related announcement.
At the same time, the National Medical Products Administration further emphasized the strict management of medical devices included in Class III and stated that starting from April 1, 2026, RF treatment devices and RF skin treatment devices that act on the human skin and subcutaneous tissue, causing pathological/physiological changes in human tissues and cells to achieve the intended use, must obtain the medical device registration certificate in accordance with Announcement No. 30. Otherwise, they cannot be manufactured, imported, or sold. This also signifies that RF beauty devices have officially entered a two-year grace period.
It is worth noting that while granting a buffer period for RF beauty devices, the National Medical Products Administration has also provided an appropriate grace period for products that have already been registered and marketed.
According to the announcement, products that obtained Class II medical device registration certificates before the issuance of Announcement No. 30 in 2022 will remain valid within the validity period of the original certificates. Products produced within the validity period of the registration certificates can continue to be sold within the product’s period of use. For registration certificates that are due to expire before April 1, 2026, the registrant can apply for an extension of the original registration certificate with the original approving department, with the maximum extension period not exceeding March 31, 2026.
In fact, before this policy change, several industry insiders had previously mentioned rumors of the extension of the implementation of regulations for RF beauty devices to CHAILEEDO. Taking into account the background mentioned above, this announcement and interpretation will ‘resurrect’ the RF beauty device market. Both companies that have not obtained Class III medical device registration certificates and products that have previously obtained Class II certificates will have the ‘ticket’ to re-enter the RF beauty device market.
The beauty device market has been in constant turmoil.
Since the issuance of Announcement No. 30, rumors of “price cuts,” beauty device companies “closing down,” and “layoffs” have emerged one after another. Behind these rumors, the RF beauty device market has experienced a period of instability, posing significant survival challenges for many companies.
On the other hand, leading beauty device brands are actively betting on the “post-RF beauty device era” by expanding their product lines and introducing various alternative products, including photoelectric devices, ultrasound devices, transdermal devices, and more. Examples include Ulike’s Super Light Cannon Beauty Device, Jmoon’s Transdermal Collagen Light Beauty Device, AMIRO’s Hyaluronic Acid Essence Cannon, Tripollar’s Inspire Sculpting and Rejuvenating Device, YA-MAN’s MAX 3rd Generation Beauty Device, and so on.
So, how do beauty device companies view this policy change? Will they reintroduce RF beauty devices in the future?
Chen Qing, a product manager of a household beauty device brand, stated to CHAILEEDO, “The content of this notification is not significantly different from the previous one, except that the government has extended the deadline for ‘RF beauty devices’ by two years.”
Regarding whether they will continue to reintroduce RF beauty devices in the future, CHAILEEDO interviewed several beauty device brands. The customer service of OGP Time Skin’s flagship store on Xiaohongshu (Little Red Book) stated to CHAILEEDO, “We should reintroduce them in the future”; customer service representatives from AMIRO, Mary Fairy, YA-MAN, and other brand flagship stores stated that they have not received any notifications for now.
Experienced professionals in the beauty device industry hold a cautious attitude, stating, “There are still many variables in the RF beauty device category. The policy adjustments are too rapid, and it is unknown whether businesses will continue to launch RF beauty device products and whether the products will remain the same as before the new regulations.”
An employee of a beauty device brand disclosed to CHAILEEDO that they should still reintroduce RF beauty devices in the future but “might change the product name (not using the term ‘RF beauty device’ in the marketing)” and mentioned they would observe “which brand will be the first to adopt the claim of RF beauty devices.”
Furthermore, according to the recent interpretation of the classification of RF treatment devices and RF skin treatment devices published by the National Medical Products Administration, if the expected use does not fall under the circumstances specified in Announcement No. 30 and is only for “non-invasive transdermal promotion of essence (not for promoting drugs and medical device absorption), enhancing essence absorption, surface cleansing of the skin, thermal massage, physical massage, skin relaxation, or exfoliation” or similar purposes, it does not meet the definition of medical devices and is not subject to medical device regulation.
There are still no brands that have obtained a medical device registration certificate, and the effects of the policy are yet to be tested.
It is worth mentioning that as of today, more than three months after the policy deadline on April 1st, no beauty device brands have obtained Class III medical device registration certificates. A public search by CHAILEEDO revealed that there are currently five beauty device brands publicly stating that they are undergoing the registration process for Class III medical devices. These brands are YA-MAN, FLOSSOM, AMIRO, OGP Time Skin, and Mary Fairy.
Among them, CHAILEEDO found clinical trial registration information for YA-MAN, FLOSSOM, AMIRO, OGP Time Skin, and other four beauty device brands on the National Ministry of Science and Technology’s government service platform.
In addition, the Chinese beauty device brand Mary Fairy publicly announced in July last year that it had completed clinical trial registration with the Guangdong Provincial Drug Administration in 2023 and became one of the first home beauty device brands to conduct multicenter clinical trials of RF beauty devices as medical devices.
Regarding the progress of brand certification, the customer service of OGP Time Skin’s Tmall flagship store told CHAILEEDO that they are currently in the final stage of applying for and obtaining the Class III medical device registration certificate and stated that they will receive the qualification certificate after the approval is completed.
The customer service of YA-MAN’s Tmall flagship store told CHAILEEDO that YA-MAN has been selected in the first batch of clinical trial lists by the National Medical Products Administration and is also one of the first home beauty device brands to pass the registration clinical trial for Class III medical devices. They mentioned that the application work is currently progressing steadily.
It is worth noting that most of the above-mentioned companies completed clinical trial registration around March 2023, which is over a year ago. This reflects the significant difficulty for most beauty device brands to obtain Class III medical device registration certificates.
In fact, the market impact caused by Announcement No. 30 has already taken effect. For example, YA-MAN, which once ranked first among beauty device brands, is now facing a sharp decline in performance. According to recent financial reports, from May 2023 to April 2024, YA-MAN’s revenue decreased by 25.5% year-on-year to 1.447 billion yuan, and its net profit attributable to shareholders plummeted by 89.8% to 18 million yuan, marking its worst performance in recent years.
An employee of a well-known leading beauty device brand also candidly told CHAILEEDO that the company is facing significant difficulties this year and described the company’s situation as “struggling to survive.”
Therefore, although this extension provides an opportunity for companies still in the process of obtaining certificates to catch their breath, it is still unknown how much it will contribute to their development and whether the RF beauty device market will experience another decline after 2026, replicating the chaotic situation of a “dive.”
