国产射频微针正式进入“械三时代” 首张三类证落地深圳

Core Insights - The approval of the first domestic Class III medical device registration certificate for gold microneedles by Shenzhen Peninsula Medical Group marks a significant shift in the domestic radiofrequency microneedle industry, indicating the entry into a new regulatory era [1] Industry Overview - The radiofrequency technology has transitioned from the telecommunications sector to the medical aesthetics industry, becoming a popular tool for skin rejuvenation by stimulating collagen production [2] - The demand for radiofrequency beauty devices has surged, leading to a trend of miniaturization, with professional equipment evolving into home-use devices [2] - To address quality issues and market chaos, the National Medical Products Administration (NMPA) classified radiofrequency beauty devices as Class III medical devices in March 2022, enforcing strict regulations [2] Regulatory Changes - The NMPA mandated that all related products must be certified by April 1, 2024, prompting many brands to initiate clearance sales and some to exit the market [2] - In July 2024, the NMPA announced an extension of the management regulations for radiofrequency treatment devices by two years, allowing a transitional period where Class II certificates remain valid [2] Company Achievements - Peninsula Medical Group's acquisition of the first Class III certificate for domestic radiofrequency treatment devices is attributed to its proactive approach, having initiated clinical trials in early 2022 [3] - The clinical trials, conducted in collaboration with the Chinese People's Liberation Army General Hospital, demonstrated significant efficacy in scar improvement, with over 90% participant satisfaction [3] - As a leading enterprise in energy source medical devices and a recognized "little giant" in specialized innovation, Peninsula Medical has established a strong patent portfolio, holding 232 technology patents globally, with 85 authorized [3] - The company's products have gained international recognition, being utilized in various prestigious medical institutions, marking a transition from domestic replacement to international acceptance [3]