We are thrilled to share that our company has once again achieved a groundbreaking milestone-we have officially obtained the world's second NMPA Class III medical device registration for our sepsis rapid testing kit! And here's what makes it even more remarkable: the very first NMPA Class III certification in this category was also awarded to us.
Our latest approved kit includes 4 detection targets, covering 25 species of Gram-negative bacteria and 8 fungal pathogens. This comprehensive panel enables rapid, accurate, and early identification of sepsis-causing pathogens-critical for timely intervention and improved patient outcomes.
Sepsis remains a life-threatening condition with a high mortality rate, especially when diagnosis is delayed. With this new addition, we are better equipped to empower clinicians with cutting-edge tools to enhance sepsis diagnosis, optimize antimicrobial stewardship, and ultimately improve prognosis and survival rates across world's healthcare system.
What makes this achievement even more significant?
As the highest and most stringent regulatory class for medical devices in China, it is not just another regulatory approval. The NMPA Class III certification is widely recognized as one of the most stringent medical device approvals globally, on par with the U.S. FDA PMA (Premarket Approval) and EU CE marking under IVDR. It requires:
√ Rigorous multi-center clinical trials with large sample sizes
√ Comprehensive performance validation including sensitivity, specificity, and reproducibility
√ Strict review of manufacturing quality systems and post-market surveillance
√ Proof of clinical utility and significant patient benefit
This certification is not easily granted--it demands uncompromising scientific evidence, robust quality control, and demonstrated clinical value. Securing not just one, but two world-first NMPA Class III approvals in this field speaks volumes about our technological leadership and unwavering commitment to fighting sepsis.
We are proud to lead the way, and we remain dedicated to driving innovation that saves lives. A huge thank you to our incredible R&D, regulatory, and clinical teams-and to our partners and customers who trust and challenge us to do better every day.
Onwards, in the fight against sepsis.
