Shin Poong Pharmaceutical receives MFDS approval for first domestically developed artificial kidney machine

Shin Poong Pharmaceutical has achieved a significant milestone, securing MFDS (Ministry of Food and Drug Safety) approval for its domestically developed artificial kidney machine. This marks the first instance in South Korea where an artificial kidney machine, created through in-house development, has received such regulatory clearance. The company announced on the 11th that it obtained the item approval (No. Jeheo 26-478) for the hemodialysis machine.

With this approval, Shin Poong now possesses all essential medical devices for hemodialysis, including dialyzers (hemodialysis filters), artificial kidney water purifiers, and the artificial kidney machine itself. Previously, the company had already secured MFDS approval for 11 types of dialyzers, continuous renal replacement therapy (CRRT) machines for intensive care units, and portable water purifiers for artificial kidneys.

The domestic production of hemodialysis-related medical devices has been a government-supported initiative. The Korea Medical Device Fund (KMDF), a pan-ministerial project, selected the localization of key hemodialysis medical devices as one of its top 10 projects for 2024. Shin Poong has been actively engaged in government-funded projects for several years, collaborating with leading medical professionals from Seoul National University Hospital's nephrology department and biomedical engineering department to advance the domestic development of critical hemodialysis equipment.