The radio frequency beauty market in China is vast and profitable for numerous brands. However, safety concerns have frequently arisen in this rapidly growing industry. To address these issues and ensure consumer protection, on 12 April 2023, the Chinese government introduced new regulations to standardize the market. The newly released Guidelines for the Registration of Radio Frequency Beauty Machine (hereinafter referred to as Guidelines) specifies regulatory requirements for radio frequency beauty machine, covering the definition, technical requirements, registration dossier, risk assessment, and control, etc.
Recognizing the significance of the newly released guidelines, ZMUni has taken the initiative to break down them for a better understanding of their implications. By providing a comprehensive analysis of the new regulations, ZMUni aims to help brands, manufacturers, practitioners, and consumers navigate the updated regulatory landscape.
I. The Definition of Radio Frequency Beauty Machine
Radio frequency beauty machine refers to products that use a specific frequency of radio frequency current (usually above 200 kHz) or electric field (usually 13.56 or 40.68MHz) to achieve the thermal effect, so as to treat skin relaxation, reduce skin wrinkles, shrink pores, tighten / improve skin tissue, or treat acne, scar, or reduce fat (fat softening or decomposition). The radio frequency beauty devices described in the Guidelines include both stand / desktop (large) devices (usually operated by network power supply) and handheld (small) devices (usually operated by internal power supply).
II. Radio Frequency Beauty Machine is Regulated as Class III Medical Device
Under the Guidelines, radio frequency beauty machine is regulated as Class III medical device, the strictest regulation for medical device in China. Additionally, it requires clinical trials, which costs around 4-5 million RMB.
Therefore, following the inclusion of radio frequency beauty machine into the Class III machine device, companies are required to invest more resources in various aspects, especially research and development, efficacy evaluation, clinical trial, safety assessment, and control, etc. It presents challenges for brands and manufacturers, as they must adapt to the new regulations and allocate additional resources to meet the stringent criteria.
III. The Naming of Radio Frequency Beauty Machine
With regard to the Guidelines, the product name shall reflect the intended application site (e. g. skin) and treatment method (e. g. microneedle).
IV. Five Technical Requirements for Radio Frequency Beauty Machine
1. Basic information
The output mode, therapeutic electrode, and expected application site of each mode should be specified.
2. Performance indicator
The operating frequency, connected load, power rating, and output voltage of each mode shall be specified, as well as the output energy and energy density of all available therapeutic electrodes.
3. Function
Temperature measurement function, cooling function, and negative pressure function shall be specified if products have these functions.
4. Electricity safety
Electricity safety of products shall meet the requirements set in GB 9706, the basic standard for medical electrical equipment in China.
5. Electromagnetic compatibility
Electromagnetic compatibility shall meet the requirement set in YY 9706, GB 9706- (the basic standard for medical electrical equipment in China), and GB 4824 (Industrial, Scientific, and Medical Equipment—Radio-Frequency Disturbance Characteristics—Limits and Methods of Measurement)
V. Registration Dossier Required for Radio Frequency Beauty Machine
According to the Guidelines, the research data required to provide includes performance, mechanism of action, quantitative relationship and energy safety, software, biological characteristics, cleaning/disinfection/sterilization, stability, animal testing, use environment, and other studies.
Following the inclusion of radio frequency beauty machine into Class III medical device management, companies must adapt to the new regulations and allocate additional resources to meet the stringent criteria. The increased requirements signify a rise in the underlying costs associated with the devices since it requires investing more resources in various aspects, such as production, research and development, clinical trial, and efficacy evaluation experiments. This presents challenges for manufacturers and brands. However, the heightened requirements and associated costs are expected to contribute to a more secure and reliable radio frequency beauty market, benefiting both consumers and the industry as a whole.
Written by Yingying
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