Group 1 - The core point of the article is that Opcon Vision has received a Class III medical device registration certificate for its new product, "soft hydrophilic contact lens," from the National Medical Products Administration of China [1] - Opcon Vision's revenue composition for the year 2024 is as follows: 56.18% from rigid corneal contact lenses, 20.04% from the medical sector, 19.47% from other optometry and professional services, and 4.31% from non-optometry and others [1] - As of the report, Opcon Vision has a market capitalization of 14.4 billion yuan [1]

Core Viewpoint - The company has received regulatory approval for its new medical device product, indicating a significant advancement in its product offerings and potential market opportunities [2]. Company Summary - The company's wholly-owned subsidiary, Opcon Vision Investment Co., Ltd., has a controlling stake in Jiangsu Duozhi Medical Technology Co., Ltd. [2]. - Jiangsu Duozhi Medical has recently obtained the Medical Device Registration Certificate from the National Medical Products Administration of China for its "soft hydrophilic contact lens" product, which is classified as a Class III medical device [2].

Core Viewpoint - The company has successfully registered a new product, a daily wear soft hydrophilic contact lens, which has received a Class III medical device registration certificate [1] Product Details - The new product is composed of HEMA, NVP, GMMA, EGDMA, and coloring agents, and is packaged in a light blue PP cup [1] - The lens has a nominal water content of 43% and is recommended for daily replacement [1] - The product undergoes moist heat sterilization and has a shelf life of 5 years [1] - It is intended for daily wear to correct myopia in patients without contraindications [1] - The registration certificate number is 国械注准20253162076, valid until October 20, 2030 [1]

Core Viewpoint - The National Medical Products Administration (NMPA) has reported five cases of illegal medical device sales online, highlighting the need for stricter regulation in the rapidly growing e-commerce sector for medical devices [1][3][4]. Summary by Relevant Sections Regulatory Actions - The NMPA has been actively addressing illegal activities in the online medical device market, having reported ten batches of typical cases since 2023, totaling 52 cases [1][4]. - The recent cases involved various e-commerce platforms such as Ele.me, Meituan, JD.com, Tmall, and Xianyu, with violations including unauthorized expansion of business scope and selling unregistered third-class medical devices [1][3]. Market Growth and Challenges - The online medical device market in China has seen explosive growth, with the number of companies engaged in online sales increasing from 8,717 in 2018 to over 360,000 by May 2023 [3]. - This rapid expansion has led to numerous irregularities, necessitating enhanced oversight to ensure public safety and compliance within the industry [3][4]. Compliance and Responsibilities - The NMPA has emphasized the importance of both online sellers and e-commerce platforms adhering to regulatory standards, including the establishment of a quality management system for online sales [6][7]. - E-commerce platforms are required to conduct real-name registration of sellers, implement quality management audits, and establish complaint and reporting mechanisms [7][8]. Future Directions - The NMPA has introduced the "Quality Management Specifications for Online Sales of Medical Devices," which will take effect on October 1, 2025, to further strengthen regulatory compliance [6]. - There is a call for improved collaboration between national and local regulatory bodies, as well as the establishment of a unified reporting channel for violations [5][6].

Core Viewpoint - The company Oupankangshi has announced that its subsidiary Jiangsu Duzi Medical Technology Co., Ltd. has had its application for the medical device "soft hydrophilic contact lens" accepted by the National Medical Products Administration of China, marking a significant step towards product registration and market entry [1] Group 1 - The product is classified as a Class III medical device in China, intended for daily wear to correct refractive errors [1] - The application has been assigned the acceptance number CQZ2501262 and is currently in the registration application acceptance stage [1] - The product has undergone clinical research and usage both domestically and internationally, with good sales performance in the global market [1] Group 2 - There are already similar products available in the domestic market, indicating a competitive landscape [1] - The product must pass technical review to obtain the registration certificate before it can be produced and sold [1]