Starting in April, RF-based medical aesthetic devices will be fully certified for operation, and the industry is ushering in a compliance overhaul.

What Safety Incidents Have Driven Stricter Regulation of AI · Radio Frequency Medical Aesthetic Devices?

Reporter Han Liming, 21st Century Business Herald

On April 1, 2026, radio frequency treatment devices and radio frequency skin treatment devices officially entered a new stage of strict regulation and high compliance.

Pursuant to the Announcement of the National Medical Products Administration on Further Clarifying Requirements for Radio Frequency Treatment Device-Related Products (Announcement No. 84 of 2024), starting from April 1, 2026, radio frequency treatment devices and radio frequency skin treatment device-related products mentioned in the Announcement on Adjusting Certain Contents of the Medical Device Classification Catalog (Announcement No. 30 of 2022, hereinafter referred to as the “No. 30 Announcement”) that have not lawfully obtained medical device registration certificates may not be produced, imported, or sold.

The No. 30 Announcement clarifies that radio frequency treatment devices and radio frequency skin treatment device-related products that act on human skin and subcutaneous tissue, causing pathological/physiological changes in human tissues and cells, and are intended to treat skin laxity, reduce skin wrinkles, tighten pores, firm and lift skin tissue, or treat acne and scars, or reduce fat (soften or break down fat), are to be managed as Class III medical devices.

A relevant person in charge of a medical aesthetic platform told a reporter from 21st Century Business Herald that the state has released an extremely strong compliance signal. Radio frequency devices have been clearly included in the management of Class III medical devices. After the transition period ends on April 1, 2026, they will fully be required to “work with licenses,” cracking down on “three-nothing” products from the source. Policy compliance has become an irreversible trend that the industry cannot change.

Against this backdrop, what adjustments will be made to the market structure, price trends, and regulatory ecosystem of radio frequency medical aesthetic devices?

Current Market Access Status

Class III medical devices are the medical device category with the strictest regulation and the highest entry threshold in China. Their approval process is lengthy, clinical requirements are high, and R&D investment is substantial. From initiating clinical trials to finally obtaining approval often takes several years, requiring multiple rounds of expert review and long-term follow-up verification to ensure the product’s safety and efficacy in clinical scenarios. Therefore, “medical device three certificates” is not only the compliance bottom line, but also a core embodiment of technological strength and market competitiveness.

A reporter from 21st Century Business Herald learned from the official website of the National Medical Products Administration that a radio frequency treatment device approved in November 2021—made by Detech (Changsha) Medical Equipment Technology Co., Ltd.—is still managed as a Class II medical device, used to help reduce skin wrinkles, with the registration certificate valid until November 3, 2026.

According to the requirements of the No. 30 Announcement, for products that had already obtained Class II medical device registration certificates before the No. 30 Announcement was issued, the original registration certificate remains valid during its validity period. Products manufactured during the validity period may continue to be sold within the product’s intended service life.

In addition, there are already domestic companies such as Hangzhou Time Machine, Jinmo Technology, Hangzhou Rebi Medical Technology, Shenzhen Zongjiang Technology, Shenzhen Yushi Technology, Guangdong Yasi Electronics, Rehfyme, Huazhi Beauty, Weimai Medical, Peninsula Medical, Wuxi Weimai Tong, and Prometheus Miracle (Shenzhen) Medical Technology that have obtained Class III medical device registration certificates for radio frequency skin treatment devices.

Image source: Official website of the National Medical Products Administration

From the perspective of usage scenarios, products from Rehfyme, Peninsula Medical, Wuxi Weimai Tong, and Shanghai Weimai Medical have been approved for use in medical institutions, to be operated by professional medical personnel. Products from Hangzhou Time Machine, Jinmo Technology, and Huazhi Beauty have been approved for use by individuals on their own in home environments.

It is worth noting that in August 2025, Aimeike completed its acquisition of Shanghai Weimai Medical and formally entered the field of medical aesthetic energy-source equipment. According to the materials, Shanghai Weimai Medical’s radio frequency skin treatment device obtained the three certificates in March 2026. This product uses radio frequency thermal effects to reduce mild to moderate wrinkles on the middle and upper face, and it cannot be used around the eyes or on the nose.

As the number of licensed enterprises gradually increases, market competition is becoming more intense. Will the prices of radio frequency skin treatment devices further decline?

In the medical aesthetic scenario, a relevant person in charge from the aforementioned platform analyzed that the total market size of radio frequency projects represented by Thermage is still expanding, but the growth logic has changed. On the one hand, demand for anti-aging across the population and compliance needs released in down-tier markets are continuously expanding the consumer base. On the other hand, price-sensitive customer groups are being diverted by projects such as micro-needling and youth injection treatments. However, Thermage’s unique advantages in non-invasive tightening, jawline contour enhancement, and eye-area rejuvenation are difficult to be fully replaced in the short term.

In the at-home beauty device market, the radio frequency category maintains rapid growth. According to the beauty device market observation jointly released by Magic Mirror Insights and Xinhua News Agency, sales revenue of radio frequency products increased by 202% year over year, with related topic volume reaching 85,500, a year-over-year increase of over 15%. Among beauty device technology discussions, it has maintained the top position. Consumers’ willingness to pay for products with “perceivable effects” is rising. Thanks to long-term anti-aging recognition and the backing of medical device three certificates compliance, trust in radio frequency technology is significantly higher than in other categories.

As the comprehensive implementation of medical device three certificates is fully carried out, the industry landscape is further diverging. According to beauty device market observations, on the one hand, entry barriers have increased substantially. Small and medium-sized brands that do not have the required qualifications are gradually being phased out, further intensifying the “head effect.” On the other hand, companies that obtain approvals first are leveraging their “first-mover advantage” to quickly capture mainstream market share for radio frequency beauty devices, further widening the gap with latecomers.

Continuous Regulatory Tightening

Behind the tightening of regulation of radio frequency treatment devices and radio frequency skin treatment devices are prominent issues such as product safety problems and failure to meet quality standards exposed by the industry’s early “barbaric growth.”

For example, publicly available information shows that during China’s “3·15” Consumer Rights Day in 2021, the China Academy of Inspection and Quarantine Sciences and China Electronics News jointly conducted a “Comparative Test of Home-Use Beauty Devices.” Eight radio frequency beauty devices on the market were tested for temperature, electrical safety, and other aspects. Among them, the Chupu Beauty Device Stop Eye test did not meet the standard. During use, the temperature reached over 60°C at its highest point, presenting a significant burn risk.

In August 2022, New Corner (Shenzhen) Technology Co., Ltd., in accordance with the requirements of the Interim Measures for the Administration of Consumer Product Recalls, proactively reported a recall plan to the State Administration for Market Regulation. The company recalled 182,215 units of the first-generation Chupu-branded Stop Eye model home-use radio frequency beauty devices imported between March 2020 and September 2021.

For enterprises, the value of implementing medical device three certificates far exceeds simply meeting compliance requirements. As Class III medical devices, related products must pass rigorous clinical trials and safety validation. Their approval of medical device three certificates also reinforces the company’s compliance credentials.

In fact, multiple places have also issued relevant policies to support the development of compliant enterprises. For example, under the relevant implementation rules for Kunshan City effective from January 1, 2026, explicit support is provided to enterprises that obtain Class III medical device registration certificates for electronic medical aesthetic products.

In addition to raising standards, local regulatory departments have also increased enforcement efforts in parallel. In March 2026, the Shantou Municipal Market Supervision Administration issued a notice on a special inspection, launching a city-wide special rectification of medical device quality and safety in the medical aesthetics industry, continuing until the end of the year. The campaign covers medical aesthetic institutions, daily beauty salons, operating enterprises, and temporary business premises. It focuses on products such as photoelectric equipment, sodium hyaluronate injection products, and implantable consumables, and severely cracks down on behaviors including using unlicensed products, illegal operations, missing purchase verification, and violations in online sales.

In addition, the Jiulongpo District Market Supervision Bureau in Chongqing, together with the Yuzhong District Market Supervision Bureau, carried out cross-regional coordinated law enforcement. It conducted special inspections of medical device use in medical aesthetic institutions, focusing on procurement channels, qualification documents, storage management, usage registration, and maintenance and upkeep. More than 10 medical devices were inspected in total. Regulators strictly investigated unlicensed, expired, and source-unknown products, and urged institutions to implement their main responsibility for quality and safety.

Looking back on the development history of the domestic radio frequency skin treatment device industry, it is a transformation story evolving from “barbaric growth” to “deep compliance.” As radio frequency skin treatment devices are included in the regulation of Class III medical devices, the industry enters a period of accelerated clearing of small and mid-sized brands and industry reshaping in which leading enterprises focus on R&D. Compliance has always been the core dividing line driving industry iteration and upgrading. (Intern Jiang Yutong also contributed to this article.)