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The National Medical Products Administration (NMPA) has issued Announcement No. 30, classifying RF therapeutic instruments and RF skin treatment instruments as Class III medical devices. This regulation, effective April 1, 2024, mandates that these products must obtain a medical device registration certificate before production, import, or sale.

Driven by consumer demand for enhanced appearance, the home-use RF beauty device market has surpassed ¥10 billion. However, the sector is plagued by issues such as exaggerated marketing, inconsistent product quality, and safety incidents. Recent reports highlighted a consumer burn injury caused by excessive heat from an RF beauty device recommended by a prominent influencer, drawing significant public attention. Numerous complaints and negative feedback underscore consumers' strong demand for standardized regulation. The ambiguous classification of RF devices between medical equipment and small appliances has long hindered effective oversight, making industry regulation an urgent necessity.

Announcement No. 30 aims to ensure enterprises uphold their primary responsibility for product quality and safety, strengthen lifecycle quality management, and guarantee product safety and efficacy, thereby promoting industry standardization. Products meeting specific criteria will be managed as Class III medical devices. China's stringent medical device classification system designates Class III as the highest tier, requiring rigorous control. Relevant products must demonstrate safety and effectiveness through clinical trials and obtain a registration certificate before market entry. This strict approval process and substantial R&D investment will raise industry barriers, weeding out less innovative companies and shifting competitive focus to product and research capabilities.