Core Viewpoint - The company has received ISO13485:2016 certification for its medical device quality management system, indicating compliance with international standards in the medical device industry [1] Group 1: Certification Details - The certification was issued by DEKRA, a leading independent certification body, covering the entire process of design, development, production, and sales of intraocular lenses for cataract and presbyopia patients [1] - ISO13485 is recognized by global regulatory bodies such as China's NMPA, EU's CE, and the US FDA, focusing on patient-centered risk management and quality control throughout the product lifecycle [1] Group 2: Implications for the Company - The achievement of this certification demonstrates the company's commitment to enhancing its quality management system and signifies its capability in medical device quality management, risk control, and compliance operations at an international standard [1] - This important qualification lays a solid foundation for the company to further expand into international markets [1]

Core Viewpoint - The company, Gaoshi Medical (02407), has announced that its subsidiary, Gaoshi Tailiang Medical Technology Co., Ltd., has officially received ISO13485:2016/EN ISO13485:2016 medical device quality management system certification from DEKRA, indicating compliance with international standards in quality management for medical devices [1] Group 1: Certification Details - The certification covers the entire process of design, development, production, and sales of intraocular lenses used for treating cataracts and presbyopia, along with their associated implantation systems [1] - DEKRA, established in 1925, is a globally recognized independent non-listed professional inspection, testing, and certification organization [1] Group 2: Importance of ISO13485 - ISO13485 is a specialized quality management system standard for the medical device industry, focusing on patient-centered risk management and comprehensive quality control throughout the product lifecycle [1] - Achieving this certification signifies that the company has established a quality management system that meets regulatory requirements and is committed to continuous improvement [1] Group 3: Strategic Implications - The acquisition of this important qualification demonstrates the company's determination to enhance its quality management system and indicates that it has reached international standards in medical device quality management, risk control, and compliance operations [1] - This certification lays a solid foundation for the company to further expand into international markets [1]

Core Viewpoint - The company has received ISO 13485:2016/EN ISO 13485:2016 certification for its medical device quality management system, indicating compliance with international standards in the medical device industry [1] Group 1: Certification Details - The certification was issued by DEKRA, a leading independent certification body established in 1925, covering a wide range of industry sectors [1] - The certification encompasses the entire process of design, development, production, and sales of intraocular lenses for cataract and presbyopia patients [1] Group 2: Importance of Certification - ISO 13485 is recognized by global medical device regulatory bodies such as China's NMPA, the EU's CE, and the US FDA, focusing on patient-centered risk management and quality control throughout the product lifecycle [1] - Achieving this certification demonstrates the company's commitment to enhancing its quality management system and signifies its capability in medical device quality management, risk control, and compliance operations at an international standard [1] Group 3: Market Implications - The acquisition of this important qualification lays a solid foundation for the company to further expand into international markets [1]

Core Viewpoint - The announcement highlights that the company's wholly-owned subsidiary, Gaoshi Tailiang Medical Technology Co., Ltd., has received medical device registration approval from the Guangdong Provincial Drug Administration for its "artificial lens implantation system" [1] Group 1: Product Details - The artificial lens implantation system is designed for use in micro-incision cataract surgery, optimizing the surgical incision to less than 1.8mm, which minimizes corneal trauma and accelerates postoperative recovery [1] - The product is an original design by Gaoshi Tailiang and has been granted an invention patent [1] Group 2: Regulatory Approval - The approval from the Guangdong Provincial Drug Administration marks a significant milestone for the company, as it allows the commercialization of the new artificial lens implantation system [1] - This system is compared to the one approved in 2024, indicating advancements in surgical techniques and technology [1]