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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].