We’ve been honing our understanding on the current thinking behind legislations and rules issued by regulatory bodies such as the National Health Commission and the National Medical Products Administration (NMPA, formerly known as CFDA). The insights we get through meticulous research and dedicated analytics continue to inform our decision making and have laid a solid foundation for our product's compliance effort.
We have always put a premium on what patients truly need in developing products and providing services of highest quality. We have standardized the entire process from product design and development, design verification to process confirmation and design conversion in compliance with all pertinent laws and regulations. Rigorous risk management is carried out throughout the product life cycle to fully guarantee the safety and efficacy of our products.
Grounded with extensive interdisciplinary experience, cutting-edge technologies, and sharp market acumen, guided by industry trends and practical demands from the market, we aim to best define a product from its earliest stage and develop regulatory clearance strategies tailor made for different products to ensure efficient approval process.
Due to the novel and innovative nature of our products, we are proactively participating in the discussions of the new rule making process and advocating for the establishment of industry standards and regulations that prioritize patient benefit, minimize risks while promoting medical device innovation.