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二类医疗器械再现违规注射 韩妃整形被撤销5A评级
Core Viewpoint - The article highlights serious violations by Guangdong Hanfei Plastic Surgery Hospital regarding the promotion and use of a medical product labeled as "medical device number," leading to the revocation of its "AAAAA Medical Beauty Hospital" rating by the China Association of Plastic Surgery [1][2]. Company Summary - Guangdong Hanfei Plastic Surgery Hospital was established in September 2017 with a registered capital of 73.5 million yuan, controlled by Huang Zhaobiao and represented by Chen Jianhong [3]. - The hospital is part of a large cosmetic surgery chain that integrates clinical and research services [3]. - Since 2022, the hospital has been involved in multiple medical service contract disputes [3]. Product and Regulatory Summary - The product in question, "Silk 516 Energy Essence," is registered under the number "Xiang Medical Device Approval 20222141869" and is classified as a second-class medical device, which is only approved for external use and not for invasive injections [1][2]. - The product is manufactured by Xiangtan Huaxi Biotechnology Co., a wholly-owned subsidiary of Huaxi Biological (688363.SH) [1][2]. - The China Association of Plastic Surgery stated that the hospital's actions violated national medical device usage regulations and contradicted the integrity and quality standards required for the "AAAAA Medical Beauty Hospital" title [2]. Industry Context - The medical beauty market has seen a surge in demand for skin care products, but it is also plagued by issues such as counterfeit products and improper usage of medical devices [5][6]. - A report by Sullivan indicated that only 35% of medical beauty injectables in circulation are genuine, highlighting the prevalence of fake and substandard products in the market [5]. - Regulatory bodies, including the Guangzhou Health Commission, have initiated investigations into the hospital's practices and the use of the disputed product [6].
绽媄娅入局“械字号”,一次来自再生医学的降维打击
FBeauty未来迹· 2025-05-23 14:43
Core Viewpoint - The article discusses the launch of the RGD Recombination Collagen Repair Stick by the skincare brand Zhanmeiya under Baiao Regeneration, highlighting its entry into the medical device market and the growing intersection of regenerative medicine and the medical beauty industry [2][4]. Market Trends - The medical beauty market in China is expected to grow at a compound annual growth rate (CAGR) of 10%-15% over the next five years, potentially reaching a market size of 3.8 trillion by 2027 [4]. - The demand for perioperative care products, such as medical dressings, is growing even faster than the medical beauty market itself [4][5]. Product Development - Zhanmeiya's RGD collagen repair stick is designed to meet the increasing demand for skin barrier repair among medical beauty consumers, particularly post-surgery and for sensitive skin [7][10]. - The product utilizes advanced technologies, including "ball collagen," "ball peptide," and "ball PDRN," to enhance its effectiveness in skin repair [10][30]. Scientific Innovation - The RGD collagen repair stick features RGD-modified recombinant collagen, which allows for precise adhesion and effective repair of the skin barrier, addressing issues such as redness and pigmentation [19][24]. - Clinical results show that the product can reduce skin redness by 16.03% within 15 minutes and improve skin glossiness by 14.85% [19][20]. Competitive Landscape - The entry of Zhanmeiya into the medical device market signifies a shift towards a more scientific approach in the beauty industry, with an emphasis on research and development [12][30]. - The article notes that many beauty brands are now competing in the medical device space, leading to a rational new phase of competition characterized by quality and efficacy [5][13]. Marketing Strategy - Zhanmeiya has engaged in innovative marketing strategies, including collaborations with influencers to enhance brand visibility and consumer engagement [35][36]. - The brand's recent marketing efforts have resulted in significant sales growth, positioning it as a leading player in the market [32][35].