Korea designates 2 'urgently-needed medical devices' for dialysis of babies

South Korean government on Friday designated two devices developed by US-based companies as crucial medical supplies, as it seeks to improve dialysis treatment for newborns and young children.

According to the Ministry of Food and Drug Safety, two medical devices have been designated as scarce or in urgent need of introduction: PD Catheter from Merit Medical and Dialy-Nate Set & Dialy-Nate Catheter from Utah Medical Products.

Officials stressed that treating kidney failure is especially crucial for newborns and young patients, since any delay in treatment has a high risk of death. As such, using a size-appropriate catheter and precise control of the dialysis fluid is crucial.

The devices are used for peritoneal dialysis, a method used to remove waste from blood by having cleansing fluid flow through a tube into the abdomen. After removing waste from blood, the fluid containing the filtered waste flows out of the abdomen.

Crucial medical supplies refer to those essential to the treatment of rare or intractable diseases, and which have no substitute in the domestic market. A total of 43 devices have received the designation in Korea. As a result, the import process, including authorization, certification and reports for these devices, is greatly simplified.