Regulatory Milestone: Securing NMPA approval, China’s equivalent of the FDA, signifies a significant step for market entry
Press Release
Kipuwex and Bepsun Achieve Chinese NMPA Approval, Paving the Way for Market Expansion
Stockholm, Sweden – May 12, 2025
Kipuwex AB, a leading innovator in remote health monitoring solutions, is proud to announce that, in collaboration with our esteemed Chinese partner Bepsun, we have obtained approval from the National Medical Products Administration (NMPA), China’s equivalent of the FDA. This significant milestone authorizes the distribution and use of Kipuwex’s advanced remote monitoring technology within the Chinese healthcare system, under the brand name Isogang.
Kipuwex’s early-stage investor and strategic partner, Bepsun Eurotech Solution Oy, has already secured the Class II NMPA medical device certification for the China-specific implementation of Kipuwex technology. The certificate is held by its affiliated manufacturing entity based in Hunan, China. The product is expected to enter production and sales in the Chinese market in the near future.
This approval marks a pivotal step in our mission to enhance patient care globally. With China’s vast and dynamic healthcare landscape, the NMPA certification enables Kipuwex to introduce its non-invasive, real-time monitoring technology to a broader audience, addressing critical needs in patient monitoring.
“We are thrilled to receive the NMPA approval, which reflects our commitment to meeting stringent international standards and our dedication to improving healthcare outcomes,” said Johan Kalling, CEO of Kipuwex AB. “Our partnership with Bepsun has been instrumental in navigating the regulatory landscape, and we look forward to a successful launch in China.”
Bepsun, renowned for its expertise in medical device distribution within China, will spearhead the introduction of Kipuwex’s technology across hospitals and clinics nationwide. This collaboration ensures that healthcare providers in China will have access to advanced tools for continuous patient monitoring, ultimately enhancing the quality of care.
The Kipuwex technology offers a compact, wireless solution for monitoring vital signs such as ECG, heart rate and respiratory rate. Its user-friendly interface and real-time data transmission capabilities make it an invaluable asset for healthcare professionals seeking to optimize patient care.
As Kipuwex embarks on this exciting new chapter, we remain committed to our vision of revolutionizing healthcare through innovation and collaboration.
