RF Beauty Devices: Regulating the Market, Ensuring Safe Use

The National Medical Products Administration (NMPA) has issued new regulations classifying radiofrequency therapeutic instruments and radiofrequency skin treatment instruments as Class III medical devices. This aims to standardize the market, with production, import, and sales of unregistered products prohibited from April 1, 2024, marking the end of the 'wild growth' era for at-home radiofrequency beauty devices.

With the upgrade in mother and baby consumption, products like at-home radiofrequency beauty devices have reached a market scale of tens of billions due to claims of 'skin tightening and wrinkle reduction.' However, this has been accompanied by issues such as exaggerated advertising, inconsistent quality, and safety hazards, leading to a growing public demand for standardized management. Previously, an incident where a top influencer's recommended radiofrequency beauty device exceeded temperature limits, causing consumer burns, drew widespread attention and highlighted the urgency of industry regulation.

The release of 'Announcement No. 30' will compel companies to assume primary responsibility for product safety and implement full lifecycle quality management. Classifying compliant products as Class III medical devices means they will be subject to the strictest regulations, requiring clinical trials to prove safety and efficacy, and obtaining registration certificates before market entry. This high barrier to entry will effectively eliminate companies lacking R&D capabilities or pursuing short-term gains, promoting healthy competition focused on product and research strength.