RF Beauty Devices: Standardized Development, Leading New Industry Standards

The latest Announcement No. 30 issued by the National Medical Products Administration classifies products such as RF therapeutic instruments and RF skin treatment instruments as Class III medical devices for strict regulation. Starting from April 1, 2024, all such products must obtain a medical device registration certificate to be legally manufactured, imported, and sold, signaling that the industry will bid farewell to its past disorderly expansion and enter a new phase of standardization.

As consumers' pursuit of quality of life continues to increase, the market for household RF beauty devices has rapidly expanded to tens of billions of yuan. However, issues such as excessive promotion, uneven product quality, and frequent safety accidents in the market have attracted widespread attention, and consumers' demand for standardized industry management is becoming increasingly urgent. Previously, an incident where a consumer was injured due to temperature runaway in an RF beauty device recommended by a well-known streamer became a hot topic, which profoundly reveals the urgency and necessity of industry regulation.

The official release of Announcement No. 30 will strongly promote enterprises to effectively assume the primary responsibility for product quality and safety, and comprehensively implement a quality management system covering the entire product lifecycle. Products that meet the new regulations will be managed as Class III medical devices, the highest level, and their safety and effectiveness must be verified through rigorous clinical trials. This higher entry barrier will effectively screen out enterprises lacking core R&D investment and guide the entire industry to return to fundamental competition based on product strength and technological strength.