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率先获批超声医美器械领域“械三证”,半岛医疗破局!千亿级市场迎来洗牌时刻
Mei Ri Jing Ji Xin Wen· 2025-11-04 07:22
Core Viewpoint - The Chinese medical aesthetics device industry is entering a new development stage characterized by high standards, strong regulation, and genuine innovation, as evidenced by the approval of the first "Class III Medical Device" registration certificate for ultrasound aesthetic equipment by the National Medical Products Administration (NMPA) [1][2]. Industry Overview - The approval of the first "Class III Medical Device" certificate marks a significant shift in the medical aesthetics device market, moving towards a high-standard and highly regulated environment [2][4]. - The certification process for Class III medical devices is rigorous, comparable to that of implantable products like pacemakers and artificial joints, requiring comprehensive evidence across the entire product lifecycle [2][3]. Company Insights - The company, Peninsula Medical, has spent over a decade focusing on clinical needs and technology development, positioning itself as a leader in innovation and compliance within the domestic energy source medical aesthetics device sector [1][3]. - Peninsula Medical's commitment to compliance and high standards has allowed it to be one of the few companies to successfully navigate the Class III certification process, having initiated its clinical and registration applications as early as 2021 [3][8]. Market Dynamics - The introduction of the "Class III Medical Device" certificate is expected to reshape market competition and accelerate industry consolidation, with companies that obtain this certification gaining significant advantages in the market [5][12]. - The high technical barriers and market exclusivity associated with the "Class III Medical Device" certification are anticipated to drive revenue growth for certified companies, as downstream medical aesthetic institutions will prioritize products with this certification [5][12]. Technological Advancements - Peninsula Medical has made several original technological breakthroughs, including the "shadow launch technology" and "intelligent ultrasound imaging system," which enhance treatment precision and comfort [7][8]. - The company invests over 25% of its revenue into research and development, employing a large team of nearly 400 R&D personnel, which is among the highest ratios in the industry [7][8]. Global Expansion - Peninsula Medical is expanding its reach into global markets, having received FDA approval for its products and entering prestigious institutions in the United States, reflecting its transition from a domestic equipment manufacturer to a global trusted brand [11][12].
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
Sou Hu Cai Jing· 2025-11-03 12:17
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].
不能打的水光,央视曝光医美新骗局
3 6 Ke· 2025-08-04 23:28
Core Viewpoint - The medical beauty industry is experiencing a transition from chaotic growth to regulated development, with increasing incidents of false advertising, illegal operations, and unlicensed practices being reported [1][3][20]. Group 1: Industry Issues - Recent reports from CCTV highlighted multiple cases of malpractice in injection-based medical beauty services, emphasizing the need for heightened safety and compliance in the industry [5][19]. - The Guangdong Hanfei Plastic Surgery Hospital, despite being a licensed institution, was found to be using a second-class medical device for injections, which is against regulations [6][10]. - Another institution, Jiyuanxi Medical Beauty Clinic, was also found to be promoting a second-class medical device for injection, claiming compliance [12]. Group 2: Illegal Practices - Unlicensed beauty salons and studios are increasingly offering injection services, with over 60% of medical beauty disputes from 2016 to 2020 arising from unqualified practitioners [14]. - A Shenzhen-based beauty shop was reported to be using smuggled injection products without proper labeling or approval, highlighting the risks associated with unregulated practices [16]. - Social media platforms like Xiaohongshu have become channels for illegal service providers to connect with clients, often offering services at significantly lower prices than licensed institutions [17][19]. Group 3: Regulatory Response - In response to the rising malpractice incidents, various regulatory bodies, including the National Health Commission and the National Medical Products Administration, have intensified their oversight and enforcement actions [20][28]. - The regulatory environment is tightening, with significant penalties being imposed on institutions for violations, including fines exceeding 1 million yuan for serious infractions [24][28]. - Platforms like Douyin and Xiaohongshu are also taking measures to combat illegal medical beauty practices, with Xiaohongshu reportedly removing nearly 500,000 posts related to non-compliant medical beauty services [28][30]. Group 4: Future Outlook - The industry is expected to undergo a period of restructuring as compliance becomes a critical focus, with the potential for stricter regulations and enforcement in the near future [20][30]. - The shift towards a more regulated environment indicates that compliance will be essential for the sustainable development of medical beauty enterprises, marking a significant change in industry dynamics [30].
宝安科创“兽”群图鉴更新!一医疗器械企业连获重磅殊荣
Sou Hu Cai Jing· 2025-07-29 14:33
Core Insights - Peninsula Medical has been recognized as both a "Gazelle Enterprise" and a "Potential Unicorn Enterprise" at the 2025 China (Shenzhen) Unicorn Enterprise Conference, highlighting its rapid growth and innovation in the optical medical aesthetics sector [1][2] - The company has developed the "Peninsula White Aurora," which has been awarded as a "2025 Guangdong Province Excellent High-tech Product," showcasing its commitment to technological advancement and market leadership [1][6] Group 1: Company Achievements - Peninsula Medical's growth trajectory is marked by significant technological breakthroughs, including the launch of the Peninsula Ultrasound Cannon, the first domestically approved ultrasound medical device, which disrupts the import monopoly [2][4] - The company has over 400 R&D personnel and more than 1,000 patent applications, establishing a strong foundation for innovation and market penetration [1][4] Group 2: Product Innovation - The "Cold Picosecond" device, known as "Peninsula White Aurora," features the industry's shortest pulse width of 250ps and dual-wavelength precision control, setting a new standard for domestic picosecond laser technology [6] - This product addresses specific challenges in treating Asian skin types, effectively targeting superficial pigmentation and deep tattoos, thus enhancing its market competitiveness [6][7] Group 3: Industry Ecosystem - The ecosystem in Bao'an includes 4 global unicorns, 7 Chinese unicorns, 71 gazelle enterprises, and 28 potential and seed unicorns, creating a robust network of innovation across strategic industries such as semiconductors and renewable energy [7] - The synergy of the "industrial chain, innovation chain, and capital chain" supports the efficient operation of this enterprise matrix, with over 57,000 manufacturing companies facilitating local procurement and rapid iteration [7]
市场监管总局公布十起违法广告典型案例,涉及医美、物流等领域
news flash· 2025-07-09 08:28
Core Viewpoint - The national market regulatory authorities have intensified efforts to combat illegal advertising to prevent unfair competition and maintain an orderly advertising market, resulting in the investigation of 14,315 illegal advertising cases and fines totaling 101 million yuan by May 2025 [1] Group 1: Case Summaries - Chengdu Chenghua Hanhou Medical Beauty Hospital was fined 409,800 yuan for misleading claims about the efficacy of its medical beauty projects during live e-commerce promotions [2] - Shiyie (Zhengzhou) Network Technology Co., Ltd. was fined 200,000 yuan for false advertising regarding its medical device, claiming it could eliminate pain for three years [3] - Anhui Quankang Pharmaceutical Co., Ltd. was fined 210,000 yuan for misleading advertising about its health food products, claiming production capabilities and experience that were not accurate [4] - Hangzhou Xunyou Trading Co., Ltd. was fined 175,500 yuan for advertising a cosmetic product with misleading claims about its effectiveness in treating skin allergies [5] - Guangzhou Qihuang Medical Culture Media Co., Ltd. was fined 135,000 yuan for promoting ordinary food products with claims of treating various medical conditions [6] - Shanghai Yimo Health Management Co., Ltd. was fined 100,000 yuan for advertising ordinary food products with misleading health claims [7][8] - Qingdao Kemanqi Trading Co., Ltd. was fined 100,000 yuan for fabricating consumer testimonials regarding the effectiveness of its product in treating ailments [9] - Haikou Huaxiatong Logistics Service Co., Ltd. was fined 200,000 yuan for spreading false information about the transportation of new energy vehicles [10] - Jiangxi Tongchuang Xinxin Marketing Planning Co., Ltd. was fined 100,000 yuan for misleading advertising related to a real estate project that was not yet operational [11] - Zhongzhi Wireless (Beijing) Technology Co., Ltd. was fined 100,000 yuan for false advertising regarding mobile data plans [12]
“中国智造”显实力,半岛医疗进驻美国顶尖医疗机构
Guo Ji Jin Rong Bao· 2025-06-06 14:23
Core Insights - Peninsula Medical's product ZenTite has been installed at the Wellman Center for Photomedicine in Boston, marking a significant step in the company's global strategy and showcasing the international presence of Chinese medical aesthetic brands [1][2] - The Wellman Center, affiliated with Harvard Medical School, is a leading institution in photomedicine research and clinical applications, enhancing the credibility of the installation [1] - Dr. R. Rox Anderson, a prominent figure in laser science and medicine, led the installation, highlighting the product's acceptance by influential experts in the field [1][3] Company Developments - Since obtaining FDA 510(k) registration for its Golden Microneedle in early 2023, Peninsula Medical has accelerated the deployment of its major equipment in six renowned hospitals in the U.S., including five installations of ZenTite [2] - The company has also successfully installed its ultrasound device at the Beckman Laser Institute & Medical Clinic, marking its first entry into the U.S. market with this product [2][3] Industry Position - Peninsula Medical is recognized as a leading brand in the global photomedicine and aesthetic device market, with a strong emphasis on collaboration with clinical experts to drive product development [3][4] - The company has a significant R&D workforce, with nearly 400 researchers, representing 30% of its total employees, and holds an 80% market share in the domestic ultrasound aesthetic sector [4]
【深圳特区报】半岛医疗创始人、董事长雷晓兵:上午给图纸,下午就能拿到打印原型
Sou Hu Cai Jing· 2025-05-02 23:51
Core Insights - The founder and chairman of Peninsula Medical Group, Lei Xiaobing, transitioned from being a surgeon in Chongqing to the medical aesthetics industry in Shenzhen, emphasizing the importance of research and providing cost-effective services to the public [7][8]. Company Development - Peninsula Medical was established in 2008 by Lei Xiaobing and several colleagues with medical backgrounds, initially exploring various medical fields before focusing on dermatology [7]. - The company achieved a significant breakthrough in 2011 by collaborating with the dermatology department of the Air Force General Hospital to develop the world's first "red and blue light therapy device," which has become a standard in top-tier hospitals [7]. Location Advantage - The decision to relocate the company headquarters to Shenzhen in 2015 was driven by the city's favorable industrial environment, which supports rapid product development and production [8]. - Shenzhen's efficient supply chain allows for quick prototyping and iteration, significantly enhancing the company's competitive edge in the market [8]. Research and Development - Research and development are central to the company's growth, with approximately 400 R&D personnel, accounting for about 30% of the total workforce, and over 1,000 patent applications filed [8][9]. - The company has received over 70 global certifications, including FDA, CE, and NMPA, for its various "star products," which have positioned it as a leader in multiple segments of the medical aesthetics industry [9]. Market Position - Peninsula Medical's "Peninsula Ultrasound Cannon" dominates 80% of the domestic medical aesthetics ultrasound market, while its self-developed "Peninsula Gold Micro-needle" competes effectively with international brands and has recently obtained FDA 510(k) registration, facilitating entry into the North American market [9].
深企射频微针仪器获FDA认证,“医美之都”力拓国际市场
Zhong Guo Chan Ye Jing Ji Xin Xi Wang· 2025-03-24 08:18
Group 1 - The core point of the article is that Shenzhen's Peninsula Medical has received FDA 510(k) certification for its RF microneedle device, marking a significant milestone for domestic medical aesthetic brands in the international market [1] - Peninsula Medical, established in 2008, is recognized as a high-tech enterprise and a "little giant" specializing in the research, production, and sales of medical aesthetic equipment [1][2] - Shenzhen is positioning itself as an "international medical aesthetic capital," supported by various government policies aimed at fostering the development of the medical aesthetic industry [1][2] Group 2 - The Bao'an District Health Bureau has released guidelines to support the compliance and innovation of medical aesthetic enterprises, offering substantial subsidies for companies developing high-end medical aesthetic devices [2] - Notable companies in the Shenzhen medical aesthetic sector include Pumen Technology, Jisidi, and Peninsula Medical, with Pumen Technology being a representative enterprise listed on the STAR Market in 2019 [2] - Shenzhen ranks among the top cities for medical aesthetic industry performance, second only to Beijing, according to the "China Urban Medical Aesthetic Industry Development Index" [3] Group 3 - Other cities like Chengdu and Hainan are also striving to develop as "medical aesthetic capitals," but Shenzhen is seen as having a clear advantage due to its focus on internationalization and innovation in the industry [4] - Shenzhen's medical aesthetic landscape includes leading institutions like Pengai Medical, which became the first listed medical aesthetic company on NASDAQ in October 2019 [3][4]