On May 8, 2025, Director Liu Xianming of the Zhejiang Provincial Medical Products Administration, along with technical review experts, visited Sinboda for a special inspection and on-site guidance on the registration and filing of medical device products.
The inspection team conducted on-site visits to the company’s production workshops, R&D laboratories, and quality control centers, gaining detailed insights into the design and development process, production workflows, and quality management systems of the intended filing products. They also provided thorough and patient responses and guidance on specific issues and concerns encountered during the preparation of filing dossiers, including technical requirements, inspection and testing, and clinical evaluation. This inspection and guidance precisely addressed the company's practical needs in the registration and filing process, effectively helping to clarify the approach and define the direction forward.
Dr. Xiaohua Chen, CEO of Sinboda, expressed sincere gratitude to the Zhejiang Provincial Medical Products Administration for its proactive, “diagnostic” service approach, and affirmed that the company will strictly follow the guidance provided, reinforce its quality foundation, and strive for early product approval to deliver safe and reliable medical device products to the market.