New Opportunities in the Aesthetic Device Sector Amid Stricter Class III Regulatory Oversight
On November 23, 2023, the Center for Medical Device Standards Management of the National Medical Products Administration released the “Guiding Principles for the Classification and Definition of Ultrasound Devices for Cosmetic Use (Draft for Comment)” to solicit public comments. The release of this draft has triggered significant repercussions within the industry.
China’s medical aesthetics industry has undergone approximately 90 years of development. In recent years, the sector has demonstrated remarkable growth rates. According to data from Frost & Sullivan, the compound annual growth rate (CAGR) of China’s medical aesthetics services market was 22.5% from 2015 to 2019. Although the industry was impacted by the COVID-19 pandemic in 2020, causing the growth rate to decline to 5.7%, it rebounded swiftly in 2021 with a year-on-year increase of 21.6%. Despite the overall economic downturn and the ongoing effects of the pandemic in 2022, market confidence in the growth trajectory of the medical aesthetics services industry remained strong. According to Deloitte’s “2022 Annual Insights Report on China’s Medical Aesthetics Industry,” as pandemic restrictions are gradually lifted, China’s medical aesthetics industry is expected to maintain a growth rate exceeding 10% in the near future.
Faced with unprecedented growth potential, the medical aesthetics industry is encountering significant opportunities and challenges as aesthetic medical devices officially enter an era of regulatory compliance.
According to the Administrative Measures for Medical Aesthetic Services, medical aesthetic institutions must obtain a Medical Institution Practice License, and attending physicians engaged in medical aesthetics must hold a Physician Qualification Certificate and a Physician Practice Certificate, as well as have work experience in relevant clinical disciplines.
This signifies that the product-driven era is gradually waning, while an era driven by medical technology and safety expertise is steadily rising.
On November 23, 2023, the Center for Medical Device Standards Management of the National Medical Products Administration (NMPA) released the “Guiding Principles for the Classification and Determination of Ultrasonic Devices for Cosmetic Use (Draft for Comments)” to solicit public comments. The Draft classifies ultrasonic devices for cosmetic use into different categories and specifies the corresponding criteria for determination. According to these Guiding Principles, ultrasonic devices that utilize high-frequency ultrasound to induce tissue denaturation in the human body for cosmetic and anti-aging purposes will be classified as Class III medical devices.
A summary of the classification and determination results for medical devices from May 2023 to September 2023, totaling 261 items, among which 71 products are recommended to be regulated as Class III medical devices. Notably, five products in the field of medical aesthetics are recommended to be regulated as Class III medical devices (already implemented).
01 | Pelvic Floor Therapy Device |
The product delivers radiofrequency current to the human abdomen, internal genitalia, and external genitalia, inducing thermal effects in target tissues. This stimulates neogenesis and remodeling of collagen and elastin in the pelvic floor, enhances the elasticity and strength of fascia and ligaments, promotes blood circulation in the pelvic region, and improves cellular function and tissue metabolism. Classification Code: 09-07. | |
02 | Medium-Frequency/Laser Therapy Device |
Features laser and medium-frequency electrotherapy functions. Laser therapy or medium-frequency electrotherapy can be applied individually to the treatment area, or both modalities can be used simultaneously. Classification Code: 09-03. | |
03 | Disposable Follicular Unit Extraction Kit |
For use with the follicular unit extraction system. Classification Code: 01-00 | |
04 | Silk Fibroin Microneedle Patch (Drug-Free) |
Apply the medication to the skin, or rapidly load the drug solution using microneedles; then place the microneedle array patch on the skin surface and press down, flattening the pressure-sensitive adhesive to secure it to the skin. Classification Code: 14-01 | |
05 | Ingestible Space-Occupying Hydrogel Capsules |
The hydrogel layer can absorb water and expand to occupy space in the stomach, increasing satiety and claiming to reduce food intake during meals. The water-absorbed hydrogel layer remains in a gel-like state as it passes through the gastrointestinal tract, then releases some of its moisture in the colon, and is eventually excreted from the body as feces. Classification Code: 14-16 | |
The aforementioned information and its release mark a significant step by the state toward strengthening market regulation of aesthetic medical devices. It is believed that in the near future, as various safety production and inspection standards are gradually established, the domestic market for aesthetic medical devices will usher in a healthier and more secure development landscape.
How to leverage innovative technologies to lead new industry trends will become the top priority for medical aesthetics manufacturers! The focus is not only on core technologies but also on robust R&D capabilities. The development of the medical aesthetics industry, along with its strict regulations, is closely linked to technological advancements. The power of innovative technologies can not only enhance efficiency in the medical aesthetics sector but also drive the continuous development of China’s medical aesthetics equipment industry, enabling it to meet new challenges constantly.
As first-tier companies such as Themis and Peninsula successively submit their Class III medical device registration applications, this publication believes that the core competitiveness of domestically produced ultrasound products will gradually shift from merely obtaining registration certificates to demonstrating superior safety, efficacy, and reliability. In this context, Themis’s products, which feature integrated diagnosis and therapy as well as precise treatment capabilities, clearly hold a competitive advantage.
Overall, driven by regulatory frameworks and brand competition, the industry is poised to enter a phase of higher-quality development. For domestic aesthetic device brands to sustain high growth, they must strengthen their capabilities in branding, channel distribution, and R&D. As medical compliance becomes increasingly complex and stringent, costs related to technology, capital, time, and resources will rise significantly. Products that persist in independent R&D of advanced technologies and break through technical barriers during policy shifts will accelerate the replacement of those unable to upgrade their R&D capabilities. It is believed that medical aesthetic products will enjoy a brighter development prospect in the future, making consumers’ journey toward beauty smoother and more accessible.
References:
1、https://www.nmpa.gov.cn/ylqx/ylqxggtg/20220330144627167.html
2、https://www.nifdc.org.cn/nifdc/index.html
3. "New Regulations Issued: Will Class II Medical Device 'Ultrasound Cannon' Products Be Wiped Out? The First Class III Ultrasound Device Has Initiated Approval Application"