On August 13, Qidu Pharma and Ujoin Medical Technology, subsidiaries of the group, were officially awarded the ISO13485 certification for their Medical Device Quality Management Systems. The successful certification is of great significance for enhancing the group’s overall quality management level, accelerating its internationalization process, and improving operational quality.

ISO13485 is an internationally recognized quality management system standard specific to the medical device industry. It specifies strict quality management requirements for the entire lifecycle of medical devices, including design and development, production, storage, sales, installation, and servicing. Many countries and regions regard it as a fundamental requirement for market access. Qidu Pharma and Ujoin Medical Technology established and implemented the system in December 2021 and September 2024, respectively. In June of this year, they submitted application materials to the CQM Mark Certification Group for products such as cleaning solutions, nasal irrigation solutions, polymer pre-filled syringe assemblies, and polypropylene pre-filled syringe assemblies. Certification experts conducted a comprehensive evaluation and on-site audit of both companies from late July to early August, fully affirming their quality management system construction and operation, and approving the audit with zero deficiencies.

The group has always adhered to the principle of "Building the Enterprise on Quality" and aims to achieve "first-class quality management standards." It continuously introduces advanced quality management concepts and tools to optimize its quality management systems. Qidu Pharma implemented the Excellence Performance Model in 2022, emphasizing the "Four Strictest" quality management philosophy and promoting a quality culture of "Doing It Right the First Time." The company established and deepened the application of a "Three Comprehensives and One Integration" quality management model—covering all employees, the entire lifecycle, all processes, and intelligentization—significantly enhancing product quality, service quality, and core competitiveness. The two certified products are both independently developed. The in vitro diagnostic cleaning solution is available in four specifications: 100ml, 150ml, 250ml, and 500ml, featuring a double-cap design that ensures both operational convenience and storage safety. The nasal irrigation solution comes in three specifications—100ml, 250ml, and 500ml—catering precisely to home care, medical professional, and portable usage scenarios. Both products are manufactured using an integrated aseptic process and fully automated equipment, with an annual production capacity of 40 million bottles.Ujoin Medical Technology integrates advanced technologies such as big data and artificial intelligence into its quality management system, achieving high-level monitoring and precise control to provide customers with high-quality products and services. The certified "Polymer Pre-filled Syringe Assembly" is independently developed by the company and is the first of its kind approved for market in China. It breaks through technical barriers related to cyclic olefin polymer materials and has obtained 23 authorized patents, including 7 invention patents. The company introduced China’s first fully intelligent production line for polymer pre-filled syringes from Germany, which uses high-precision sensors and machine vision systems to monitor key parameters in real time. This has reduced changeover time from hours to minutes, increased order fulfillment speed by 700%, raised per capita productivity by 178.27%, reduced staffing requirements by 84%, and improved product pass rate per unit time by over 5%.

The group will continue to pursue its strategy of developing six major business segments, deepen its presence in the high-end medical device sector, focus on cutting-edge products and core technologies, and further advance technological innovation and quality upgrades. It will accelerate product development and market expansion, building end-to-end competitiveness from "independent R&D to high-end manufacturing to global markets," creating new advantages for high-quality development, and speeding up the company’s transformation and growth.