Shinpoong E&S announced on the 11th that it has obtained product approval (No. Jeheo 26-478) from the Ministry of Food and Drug Safety (MFDS) for its hemodialysis machine (HD·Hemodialysis machine). According to the company, this is the first time that a domestically developed hemodialysis machine has received product approval from the MFDS.

With this approval, Shinpoong E&S has now developed all key medical devices related to hemodialysis: the hemofilter (hemodialysis filter), the water purification system for hemodialysis machines, and the hemodialysis machine (HD) itself. The company had previously received MFDS product approvals for 11 types of hemofilters, a continuous renal replacement therapy (CRRT) machine for critical care, and a mobile water purification system for hemodialysis machines.

The localization of medical devices related to hemodialysis has also been promoted as a government research and development project. The Korea Medical Device Development Fund (KMDF) selected the localization of core hemodialysis medical devices as one of its top 10 flagship tasks for 2024. Over several years, Shinpoong E&S has carried out national R&D projects, working with leading domestic medical professionals, including the Division of Nephrology at Seoul National University Hospital (Professor Dong Ki Kim) and the Department of Biomedical Engineering (Professor Jung Chan Lee), to localize core equipment related to hemodialysis.

Hemodialysis is a treatment that removes waste products and excess fluid from the blood of patients with impaired kidney function. Until now, the domestic market for hemodialysis machines (HD) has relied entirely on imported products from global multinational companies.

Kang Chang-ho, head of the Hemodialysis Business Division at Shinpoong E&S, said, “We are now able to introduce products based on domestic technology in the field of hemodialysis medical devices,” and added, “Following the hemofilter and the water purification system for hemodialysis machines, we will prepare for mass production of the hemodialysis machine.”

Shinpoong E&S is developing a new product that improves the performance of its existing CRRT machine, which has already received approval. For the hemodialysis machine (HD), the company is working on a mass-production model with an added hemodiafiltration (HDF) function. It plans to launch this model on the market after obtaining sales approval.

Shinpoong E&S is establishing a hemofilter production line and medical device manufacturing facilities at its Banggyo-dong site in Hwaseong-si, Gyeonggi-do. These facilities have obtained GMP and ISO 13485 certifications.

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