MFDS designates two peritoneal dialysis medical devices for newborns and children for emergency import

[Financial News] The Ministry of Food and Drug Safety (MFDS) designated two peritoneal dialysis medical devices needed to treat severe acute kidney injury in newborns and children as medical devices for emergency import.
The MFDS said on the 6th that it had newly designated a peritoneal dialysis catheter for newborns and children and a catheter connection system as medical devices for emergency import.
The products designated this time are a peritoneal dialysis catheter sized for newborns and children and a connection system that helps accurately infuse dialysate and measure the amount drained during manual peritoneal dialysis.
Peritoneal dialysis is a treatment that uses the peritoneum of patients with impaired kidney function to remove waste products and excess fluid from the body. Because newborns and children are small, dialysate must be infused in small, precise amounts, and the volume drained must be carefully monitored. Treatment can be difficult if a catheter of the appropriate size is unavailable or dialysate is not properly managed.
The emergency-import medical device program streamlines approval, certification and notification procedures during import for products that need to be supplied quickly for public health reasons, including to treat rare and intractable diseases, so they can reach healthcare facilities promptly. Including this designation, a total of 43 products have been designated as medical devices for emergency import.
The MFDS made this designation after reviewing demand at healthcare facilities, the availability of domestic alternatives, the urgency of treatment and the results of expert deliberations, among other factors. It plans to supply suitable medical devices to newborn and child patients who need peritoneal dialysis and reduce gaps in treatment.

[email protected] Jung Sang-hee Reporter