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].

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].

Core Viewpoint - The article highlights the growing popularity of water light needles among young consumers due to their "minimally invasive beauty" characteristics, while also revealing regulatory violations in the medical aesthetics industry regarding the use of medical devices [1] Group 1: Industry Insights - Water light needles have become a preferred choice for many young individuals seeking cosmetic enhancements [1] - Some legitimate medical aesthetic institutions are found to be illegally using Class II medical products for injections, which raises concerns about consumer safety [1] Group 2: Regulatory Issues - According to the National Medical Products Administration's classification rules, injections into the skin must utilize Class III medical products [1] - A specific case was reported at Guangdong Hanfei Plastic Surgery Hospital, where Class II product "Sili 516 Energy Essence" was used for injections, violating regulations [1] - The hospital's management attempted to confuse the distinction between Class II and Class III products, misleading consumers about the safety of their procedures [1]

Group 1 - The article highlights the increasing popularity of water light injections among young people due to their "minimally invasive beauty" characteristics, but also points out the illegal practices in the industry [1][3] - Several legitimate medical beauty institutions are found to be violating regulations by using Class II medical devices for injections, which are not approved for such use [5][13] - The investigation reveals that some beauty clinics and unauthorized beauty shops are openly providing injection services without proper medical qualifications [32][41] Group 2 - The Guangdong Hanfei Plastic Surgery Hospital misleads consumers about the classification of their water light products, claiming they are safe for injection despite being Class II devices [7][15] - The Ji Yan Xi Medical Beauty Clinic is also implicated in illegally injecting Class II products, with the physician providing vague responses to inquiries about compliance [22][30] - A beauty shop named Yujianmei Technology is found to be operating without medical qualifications, using smuggled products for injections [34][39] Group 3 - The article discusses the presence of unregulated and illegal products in the market, including foreign water light injections without proper labeling and approval [41][47] - The investigation uncovers that platforms like Xiaohongshu are being used by drug dealers and unauthorized personnel to connect with customers for illegal injection services [51][57] - The report emphasizes the dangers of low-priced products being marketed as water light injections, which are actually intended for other medical uses [67][68]

Core Viewpoint - The article highlights the issue of some legitimate medical beauty institutions violating regulations by using Class II medical devices for injections instead of the required Class III products, raising concerns about consumer safety in the beauty industry [1]. Group 1: Industry Regulations - The article references the National Market Supervision Administration's regulations, which state that injections into the skin must utilize Class III medical devices [1]. - The specific product in question, "Silk 516 Energy Essence," is classified as a Class II medical device, which is not compliant for injection purposes [1]. Group 2: Consumer Experience - A report from a consumer investigation revealed that the Guangdong Hanfei Plastic Surgery Hospital, a licensed medical beauty institution, was found to be administering the Class II product for injections [1]. - The hospital's management attempted to confuse the distinction between Class II and Class III devices, suggesting that any product with a "medical device number" is safe for injection [1].

Group 1 - The article highlights the illegal practices in the beauty industry, particularly regarding the use of Class II medical devices for injection, which are not approved for such procedures [1][4][24] - Several medical institutions, including Guangdong Hanfei Plastic Surgery Hospital and Jiyuanxi Medical Beauty Clinic, mislead consumers about the safety and classification of their products, promoting Class II devices as safe for injection [6][16][26] - The investigation reveals that unauthorized beauty salons and studios are openly providing injection services without proper medical qualifications, using smuggled and unapproved products [29][33][49] Group 2 - The report details specific instances where medical professionals and institutions provided injections of products that are not legally permitted for such use, including the "Silk 516" and "Lizhulan" products [7][18][24] - The article also discusses the role of social media platforms like Xiaohongshu in facilitating the promotion and sale of these illegal beauty products, allowing unlicensed practitioners to connect with customers [44][56] - The investigation uncovers a broader issue of counterfeit and unregulated beauty products flooding the market, posing significant risks to consumer safety [38][41][47]