RAYGAME: Empowering Esports Enthusiasts

The National Medical Products Administration has issued Announcement No. 30, classifying radiofrequency therapeutic and skin treatment devices as Class III medical devices. Starting April 1, 2024, production, import, and sales without registration are prohibited, marking the end of a decade of unregulated growth in the at-home radiofrequency beauty device market.

Driven by consumer demand for enhanced aesthetics, the at-home radiofrequency beauty device market has surpassed 10 billion yuan. However, issues like exaggerated marketing, inconsistent quality, and frequent safety incidents have become commonplace. Reports of a popular influencer's recommended device exceeding temperature limits and causing burns have drawn significant attention. Consumers increasingly expect standardized regulation, but the long-standing debate over whether these are 'medical devices or small appliances' has challenged oversight, making enhanced regulation imperative.

The release of Announcement No. 30 will prompt companies to strengthen their product quality and safety responsibilities, comprehensively improve product lifecycle management, ensure product safety and efficacy, and drive the industry towards standardization. Eligible products will be managed as Class III medical devices. China's medical device classification is stringent, with Class III being the highest level requiring strict control. According to regulations, relevant products must prove their safety and efficacy and obtain a registration certificate before production and sales. Demonstrating medical device safety and efficacy typically involves clinical trials, which are time-consuming and costly. This high barrier will increase the difficulty for small appliance companies entering the medical device sector, weeding out opportunistic players and returning market competition to product and R&D strength.