The first round of penalties for the Chinese RF beauty device “registration as a medical device” has begun.
Recently, Shangpin International Beauty Technology (Guangzhou) Co., Ltd. (referred to as “Shangpin Technology”) was fined 194,400 yuan by the Baiyun District Market Supervision Administration of Guangzhou for failing to provide the corresponding medical device registration certificate for its beauty device products. This may be the first case of punishment for qualification issues with beauty devices under the new regulations.
The company was fined due to unable to provide medical device registration certificate
Chinese RF beauty devices were once one of the most popular categories in the home beauty device market.
In 2022, the National Medical Products Administration issued an announcement regarding the adjustment of certain contents of the “Classification Catalog of Medical Devices,” categorizing RF treatment devices and RF skin treatment devices as Class III medical devices. Currently, this policy has been officially implemented on April 1st of this year. According to the new regulations, “RF treatment devices and RF skin treatment devices cannot be produced, imported, or sold without obtaining a medical device registration certificate in accordance with the law.”
According to the penalty information released by the Guangzhou Credit Platform, Shangpin Technology has been producing the involved “Collagen PRO” beauty device since February 2024. The product mainly consists of RF and microcurrent electrodes, LED lights, temperature sensors, control panels, device shells, and charging interfaces. According to the product manual, “Collagen PRO” utilizes RF and microcurrents.
Among them, RF causes high-speed molecular movement in the skin, generating heat energy and synthesizing a large amount of collagen protein, effectively reducing wrinkles and restoring elasticity. Microcurrents stimulate the brain to produce unconscious muscle movements, causing the muscles to press, improving skin elasticity. EMS conducts microcurrents to the deep layers of the skin through induction electrodes, promoting collagen growth and enhancing contours. Therefore, the Baiyun District Market Supervision Administration of Guangzhou believes that the beauty device “Collagen PRO” should be classified as a Class III medical device.
However, the body of “Collagen PRO” does not have Chinese label markings indicating the product name, medical device registration certificate, manufacturing company, and other information. Shangpin Technology was unable to provide the corresponding medical device registration certificate for the mentioned product and stated that the product had not undergone medical device registration.
As a result, the Baiyun District Market Supervision Administration of Guangzhou determined that “Collagen PRO” is an unregistered Class III medical device according to the law. Shangpin Technology was fined 192,000 yuan for engaging in the production of Class III medical devices without permission and producing unregistered Class III medical devices. In addition, they confiscated illegal gains amounting to 2,400 yuan and 80 units of “Collagen PRO” from their inventory.
It is worth noting that this punishment is not the first penalty for home beauty devices after the new regulations. The difference is that the previously disclosed penalties were based on the “Advertising Law of the People’s Republic of China” rather than the “Regulations on the Supervision and Administration of Medical Devices,” and they did not explicitly mention the inability to provide the corresponding medical device registration certificate for the product in question.
For example, on May 31st, Fujian Wenyu Electronic Technology Co., Ltd. was fined 2,700 yuan for selling the product “Furanke Multifunctional Home Facial Massage RF Lifting and Tightening Eye Massager Pore Cleansing Device in Pink.” The reason for the penalty was that the product’s online promotion included content such as “RF lifting and tightening, refined pores, lifting fine lines, 68% firmness improvement, 41% reduction in fine lines.” The Market Supervision Administration of Fu’an City considered this advertisement to be in violation of Article 17 of the “Advertising Law of the People’s Republic of China,” which prohibits any advertising other than medical treatment, drugs, and medical device advertisements from involving disease treatment functions or using medical terminology or language that easily confuses medical products and drugs or medical devices.
From the Shangpin Technology penalty case, it can be seen that the focus of market regulatory authorities’ management of home beauty devices may have shifted from regulating “advertising promotion” content to stricter regulation in the “medical device” field.
Same-named products still being sold, frequent market chaos
Although the penalty order has been issued, CHAILEEDO has found during the investigation that the same-named products mentioned in the penalty order are still being sold.
Currently, in the Shangpin Technology 1688 store, there are products labeled as “Collagen PAO Beauty Device” still being sold. Although the product name is different, from the product details and packaging, it is evident that the product within the link is the “Collagen PRO” beauty device. The promotional page still mentions “RF” and “Collagen regeneration.”
Furthermore, there are still products labeled as “RF Beauty Devices” being sold in the store, and the promotional page explicitly mentions the use of RF technology, with claims of “activating deep-layer collagen” and “diminishing wrinkles and fine lines.”
In fact, CHAILEEDO’s investigation has found that Shangpin Technology is not an isolated case. Although home RF devices have been “classified as medical devices,” various RF devices can still be found on platforms like 1688. These products can be divided into two categories: first, products that do not mention “RF” in the product name and promotional details but still have RF functionality; second, companies that directly indicate the use of RF technology in the product details.
It is worth mentioning that even before the official implementation of the new regulations, on March 27th, the National Medical Products Administration released an interpretation of the classification of RF treatment devices and RF skin treatment devices. It mentioned that not all RF products belong to medical devices.
For example, RF devices used only for purposes such as “non-invasive permeation promotion for skincare essence (not for drug and medical device permeation promotion), enhancing essence absorption, surface cleansing, warm massage, physical massage, skin relaxation, and exfoliation” or similar purposes do not fall under the definition of medical devices and are not subject to medical device regulation.
In fact, this policy is considered a relaxation in the regulation of home RF devices, and some even believe that RF devices currently being sold can continue to be sold by adjusting the sales points. However, at that time, industry insiders also told CHAILEEDO that the suggestion of changing the claims, fine-tuning product parameters, and re-listing may be suspected of violations, exploiting regulatory loopholes (see CHAILEEDO’s special report “Today, RF Beauty Devices Completely Removed from Shelves!”).
From the current market perspective, there is still no shortage of companies in the home beauty device industry that engage in deceptive practices. This penalty clearly shows that the so-called “word games” strategy is not effective, and any product that uses RF technology and makes non-compliant claims will be subject to regulation under the new rules.
New products emerge frequently, and the beauty device sector is undergoing transformation.
Of course, not all home beauty device companies are trying to exploit loopholes. Currently, leading beauty device brands have removed their previously popular RF beauty device products from the market and have expressed their active efforts to apply for Class III medical device registration certificates. However, as of now, no brand has successfully obtained the certificate.
One leading beauty device brand informed CHAILEEDO that their application for a Class III medical device registration certificate is currently in progress, but since the relevant national authorities have not provided specific updates, the exact time for obtaining the certificate is still unknown.
Against this market backdrop, beauty device brands have also begun actively “rescuing” themselves and venturing into other sectors by introducing a large number of non-RF products. Taking the 1688 platform as an example, the top-ranked products in the search results, apart from basic products like massagers and essence importers, are mostly EMS microcurrent and LED mask products.
Of course, the leading brands are no exception. CHAILEEDO has found that leading beauty device brands have expanded their product lines this year and launched various alternative new products, including photoelectric devices, ultrasound devices, and permeation enhancers. Examples include Ulike’s Super Photon Cannon Beauty Device, Ji Meng’s Transdermal Collagen Light Beauty Device, Mi Guang’s Water Light Essence Cannon, Chu Pu’s Inspire Facial Sculpting Knife, and Ya Meng’s MAX 3rd Generation Beauty Device.
At the same time, in terms of niche categories, mask-type beauty devices have also been a major trend this year, such as Ulike’s White Queen Beauty Mask, Mi Guang’s Rainbow Light Mask, and Ya Meng’s Green Light Mask.
This also indicates that even though RF products have temporarily exited the market, there are still abundant opportunities to be filled in other technological fields. With consumers’ increasingly diversified demands for beauty devices, non-RF products will undoubtedly have a broader development space.
However, it is worth noting that the initial inclusion of RF beauty devices in medical device regulation was partly due to frequent safety issues in the RF beauty device market at that time. Improper use or quality defects of products caused skin allergies, facial burns, facial indentations, and other issues for many consumers.
In the current “post-RF era,” safety issues with home beauty devices continue to arise. For example, there have been recent rumors about beauty device brands causing corneal damage. Although the brand has released test reports stating that the products are safe, consumer feedback shows that there are still many doubts about the safety of beauty devices, and trust in the beauty device market has not been fully established.
With the continuous growth of the home beauty device market, strict regulation has become inevitable. This penalty not only serves as a warning to a single company but also aims to clean up and standardize the entire market. It also signifies that the regulation of home beauty devices has entered a new development stage. Therefore, brands can only establish a solid foothold in this market earthquake by continuing to focus on technological innovation and improving the safety and applicability of their products.
