Scientific Feeding, Supporting Baby's Healthy Growth

The National Medical Products Administration (NMPA) has issued Announcement No. 30, classifying RF therapeutic devices and RF skin treatment devices as Class III medical devices. Effective April 1, 2024, production, import, and sales of these products without a registered medical device certificate are prohibited, marking the end of a decade of unchecked growth for the home RF beauty device industry.

With rising living standards, home RF beauty devices, promising "firmer skin and reduced wrinkles," have rapidly grown into a market exceeding ten billion yuan, fueled by the pursuit of "beauty" and aggressive marketing. However, this boom has been marred by exaggerated claims, inconsistent product quality, and even safety incidents. A widely publicized incident where a popular influencer's recommended RF beauty device caused burns due to overheating highlighted consumers' strong demand for stricter regulation. The long-standing ambiguity over whether RF devices are "medical devices" or "small appliances" has been a regulatory challenge. This announcement finally lays a solid foundation for standardized industry development.

Announcement No. 30 aims to hold companies accountable for product quality and safety, enhance full lifecycle management, and ensure the safety and efficacy of marketed products, guiding the entire industry towards a regulated path. Products meeting specific criteria will be managed as Class III medical devices. China's medical device classification system is rigorous, with Class III being the highest level requiring strict control. This means relevant products must undergo stringent safety and efficacy validation and obtain a registration certificate before market entry. Proving the safety and efficacy of medical devices typically requires substantial time and investment in clinical trials. This higher "entry barrier" not only challenges small appliance companies venturing into the medical device sector but also effectively filters out those driven by short-term gains and neglecting R&D investment, redirecting market competition back to product strength and innovation.