On 24 March, an audit team from the Federal Service for Surveillance in Healthcare (RZN) of the Russian Federation visited our company to conduct an authenticity verification audit for medical device registration. RZN certification is a mandatory official requirement for medical devices to enter the Russian and Eurasian Economic Union markets; the audit standards are stringent, and our company attaches great importance to this process.
Efficient Cooperation Throughout Demonstrates Strength in Compliance Management
During the inspection, our core management team provided full accompaniment and efficient cooperation. With a professional and rigorous approach, they gave the audit team a detailed overview of the company’s development, core product lines and global expansion plans. Focusing on the three key areas of airway management, respiratory support, and anaesthesia and critical care, they demonstrated the company’s deep industry expertise and commitment to compliant business practices. With on-site inspections becoming increasingly rigorous, the audit team conducted comprehensive and meticulous verification and in-depth questioning regarding core modules such as the quality management system, production processes, GMP cleanrooms, equipment operation, product traceability, sterility assurance and certification documentation. Our relevant managers provided detailed responses and full cooperation throughout the process; our standardised and rigorous on-site management and quality control systems received positive affirmation from the audit team’s experts.
Zero-Defect Audit Success: Steadily Advancing International Expansion
This zero-defect audit success is a vivid demonstration of our company’s adherence to the quality policy of “Total Participation, Quality as the Soul”. It represents not only a pragmatic step in proactively advancing our global expansion and aligning with international regulatory standards, but also lays a solid foundation for subsequently opening up the Russian market and facilitating the export of high-quality medical consumables. To date, our company has registered (including pending applications) in 18 countries and regions, with business operations spanning 80 countries.
Moving forward, we will continue to strengthen internal management, deepen product innovation, and strictly uphold the safety standards for medical products. At the same time, we will continue to follow up on the subsequent procedures of the RZN audit, advancing steadily to strive for early access to the Russian market. We aim to bring Chuanfang’s high-quality medical consumables to the global stage and contribute our part to the advancement of human health.
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