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The National Medical Products Administration (NMPA) has announced that RF therapeutic instruments and RF skin treatment instruments will be managed as Class III medical devices, effective April 1, 2024. This mandates that such products must obtain a medical device registration certificate before production, import, or sale.

The at-home RF beauty device market, driven by consumer demand for aesthetic improvements, has surpassed 10 billion yuan. However, the sector has been plagued by issues including exaggerated marketing, inconsistent product quality, and safety incidents. Recent reports highlighted a high-temperature incident with a popular streamer-endorsed device, causing consumer burns and sparking widespread concern. The surge in complaints underscores the urgent need for standardized regulation. The ambiguity in classifying RF devices as either medical equipment or home appliances has hindered effective oversight, making strengthened industry regulation imperative.

Announcement No. 30 aims to hold companies accountable for product quality and safety, enhance lifecycle quality management, and ensure product efficacy, thereby promoting industry standardization. Products meeting specific criteria will be regulated as Class III medical devices. China's strict medical device classification system designates Class III as the highest tier, requiring stringent control. These products must undergo clinical trials to prove safety and efficacy, and obtain registration certificates before market entry. The rigorous approval process and substantial R&D investment will raise industry barriers, phase out companies lacking innovation, and shift brand competition towards product and research capabilities.