In recent years, active devices based on laser, ultrasound, and radiofrequency technologies have gained significant popularity in the field of aesthetic medicine due to their remarkable effectiveness and diverse applications. These devices are widely used across medical institutions, aesthetic clinics, and even in home settings. However, the rapid expansion of this market has been accompanied by a rise in adverse events related to their usage, sparking growing concerns about the safety and efficacy of these technologies.
Below article is from the Center of Medical Device Standardization of NMPA. It analyzes, from a technical perspective, the factors that need to be considered in determining the attributes of active beauty devices, taking into account their mechanisms of action, intended use, and risks during use, and provides relevant technical recommendations.
For foreign manufacturers aiming to enter or expand in China’s medical aesthetics market, understanding the regulatory classification and compliance requirements of such active devices is crucial. The first step in effective oversight—and in preparing a compliant market entry strategy—is to determine which products qualify as medical devices and are thus subject to regulation, and which do not. This classification process forms the foundation for targeted regulatory measures, shaping everything from product development to commercialization.
A Fragmented but Evolving Regulatory Framework
China’s active aesthetic device market is diverse, encompassing a broad range of technologies and treatment goals. Because of the differences in mechanism of action, application, and intended use between active and non-active devices, this discussion focuses solely on active aesthetic devices. NMPA has been exploring the classification and regulation of these devices for years. Several key regulations have been established to categorize and manage aesthetic devices. For instance, the Medical Device Classification Catalog, implemented on August 1, 2018, includes a number of aesthetic-focused products such as focused ultrasound body contouring systems, cryolipolysis equipment, laser hair removal machines, and breast augmentation systems. Devices with similar mechanisms or risks—such as low-frequency therapy instruments, radiofrequency (RF) devices, and intense pulsed light (IPL) systems—can also fall under aesthetic applications.
In May 2018, the NMPA issued a notice classifying IPL hair removal devices—commonly used in homes and beauty salons—as Class II devices, citing their structural and functional similarity to listed therapeutic devices. In March 2024, further guidance was issued on the classification of RF skin treatment devices, offering detailed interpretations of their regulatory categorization.
Despite these developments, many new and emerging aesthetic devices remain unlisted in the Classification Catalogue. This creates regulatory ambiguities and inconsistent enforcement, especially for novel or borderline technologies. These gaps have led to disputes in enforcement and confusion in the marketplace, with registered and unregistered products often coexisting within the same sales channels.
Some manufacturers deliberately avoid registration, either by claiming their products are for non-medical use in beauty salons, or because of the high cost and lengthy timeline required for medical device registration. This lack of oversight can pose risks to consumers and undermine trust in the market.
International Best Practices: Insights from the U.S. and Europe
To formulate effective regulatory policies and attract credible foreign players, China has looked abroad for inspiration.
United States
In the U.S., the Food and Drug Administration (FDA) enforces stringent regulations for aesthetic devices. Specific guidance documents have been issued for devices such as focused ultrasound systems and low-level laser systems used for cosmetic purposes. U.S. regulation focuses on the clinical mechanism of the device, rather than its ultimate outcome (e.g., beautification or therapy). If a device alters human physiology or anatomy in a way consistent with medical intervention, it is classified as a medical device, regardless of its marketed purpose.
European Union
The EU follows the Medical Device Regulation (MDR) [EU 2017/745], which includes specific definitions and classifications for aesthetic devices with medical-like functions and risks. Annex XVI of the MDR lists aesthetic devices that, despite having no intended medical purpose, are still regulated due to their similarity to medical devices. These include body contouring devices, tattoo removal systems, and liposuction equipment. Furthermore, Regulation (EC) No 1223/2009 on cosmetic products also covers certain borderline products, adding another layer of oversight.
The EU approach highlights functionality and risk equivalency with medical devices as the primary criteria for regulatory classification.
China’s Regulatory Path: Legal Foundations and Challenges
China’s regulation of aesthetic active devices draws from several foundational documents:
- Regulations on the Supervision and Administration of Medical Devices: This law provides the formal definition of a medical device, including its use in diagnosing, treating, or alleviating diseases or injuries. However, its broad language allows for varied interpretations, making consistent classification challenging in practice.
- Medical Device Classification Catalogue and Related Notices: These documents provide examples of categorized aesthetic devices, which serve as reference points for new products.
- Measures for the Administration of Medical Aesthetic Services: Article 2 of this regulation defines medical aesthetics as procedures involving surgical, pharmaceutical, or medical device interventions that impact a person’s appearance or body structure. This is further supported by a separate Directory of Graded Medical Aesthetic Projects, which includes many treatment types performed with active medical devices.
Despite these reference points, some companies continue to bypass regulatory scrutiny by claiming their products target healthy individuals, are used only in non-medical settings, or serve purely cosmetic goals. Such assertions can blur the lines between regulated and non-regulated products, creating enforcement difficulties.
Technical Recommendations for Product Classification and Regulation
To improve classification clarity and support sound regulation, the following principles are proposed for determining whether an active aesthetic device should be regulated as a medical device in China:
- Compliance with Medical Device Definition: Devices that aim to treat or alleviate diseases or physical conditions—such as RF devices for skin tightening, ultrasound lipolysis machines for fat reduction, and IPL systems for skin rejuvenation—clearly fall under the legal definition of a medical device.
- Mechanism of Action: Devices that influence the body’s physiological structures or functions—such as those that stimulate collagen production, regulate metabolic activity, or alter skin elasticity—should be regulated as medical devices, even if marketed for cosmetic purposes.
- Risk Profile: Devices using energy sources like lasers, RF, or ultrasound inherently carry safety risks, such as burns, swelling, or allergic reactions. The level of potential harm closely mirrors that of therapeutic medical devices and thus warrants similar regulatory oversight.
- Intended Use vs. Actual Functionality: Aesthetic devices should not be judged solely by their marketed intent. Classification must consider their technical function, user environment, and treatment effect. Devices mimicking medical functions or posing similar risks must be treated accordingly.
Conclusion: Opportunities for Global Manufacturers
As China tightens regulation over the aesthetic device sector, foreign manufacturers with proven technology and regulatory experience will find increased opportunity. A clear understanding of the classification criteria and regulatory expectations will enable companies to navigate China’s evolving framework more confidently.
For foreign manufacturers, especially those already operating under FDA or EU compliance, China’s regulatory trajectory signals a shift toward global alignment. Early engagement with China’s regulators, submission for registration, and compliance with local technical standards will not only ensure smoother market entry but also build long-term consumer trust and brand credibility.
By proactively aligning with China’s requirements, international manufacturers can position themselves as leaders in a market poised for both expansion and reform—offering innovative, safe, and effective aesthetic solutions to the world’s largest consumer base.
