国家药监局发出首张超声医美设备“三类证”， 再次花落深圳企业

Core Viewpoint - The "beauty economy" in Shenzhen is rapidly rising, driven by policies and innovation, with the medical beauty industry showcasing unique competitiveness [1][2]. Group 1: Industry Development - The National Medical Products Administration (NMPA) issued the first Class III certificate for ultrasound medical beauty equipment to Shenzhen Peninsula Medical Group's "Peninsula Super Ultrasound" device, marking a significant breakthrough in high-end medical beauty equipment [1][4]. - The medical beauty industry in China is expected to exceed 400 billion yuan by 2025, with the non-surgical light medical beauty market expanding rapidly due to its low risk and quick recovery characteristics [2][4]. - The term "ultrasound cannon" originated in Shenzhen, and since its launch in mid-2021, over 4 million treatments have been performed, averaging more than 3,000 treatments per day [3][4]. Group 2: Regulatory Environment - The release of the "Guiding Principles for the Classification of Ultrasound Devices for Beauty Use" by the NMPA indicates a shift towards stricter regulations for ultrasound medical beauty devices, requiring them to meet Class III medical device standards [4][5]. - The transition from Class II to Class III certification involves higher safety standards and stricter entry barriers, which can take several years to achieve [5][6]. Group 3: Technological Advancements - The "Peninsula Super Ultrasound" device is the first in the domestic medical beauty sector to incorporate an intelligent ultrasound imaging system, enhancing the precision of treatment [8][6]. - Clinical studies have shown that the device significantly improves skin laxity, with a satisfaction rate exceeding 90% among participants [6][8]. Group 4: Company Growth and Investment - Since its establishment in 2008, Peninsula Medical has become a national-level specialized "little giant" enterprise, ranking among the top six global energy source medical beauty equipment companies [9][11]. - The company invests 25% to 27% of its annual sales revenue into research and development, having obtained nearly 70 global certifications and applied for over 1,000 domestic and international patents [11].