MFDS Designates 'Self-Expanding Stent' as a Rare and Urgently Needed Medical Device for Introduction

Used for Procedures in Newborns with Congenital Heart Disease

[Asia Economy Reporter Lee Gwan-joo] The Ministry of Food and Drug Safety announced on the 23rd that it has newly designated the 'self-expanding stent' for procedures on newborns with congenital heart disease as a rare and urgently needed medical device.

The newly designated medical device is a self-expanding product inserted into the ductus arteriosus of newborns to increase blood flow. Compared to the existing balloon-expandable stents, it causes less damage and fewer complications at the procedure site, and its smaller diameter makes it a more stable product for newborn procedures.

The Ministry explained that supply applications will be possible from January next year, and when patients apply for supply, customs clearance will take about a month before the device is supplied. From January to March next year, it will be non-reimbursable, and thereafter it will proceed according to the reimbursement registration process.

So far, the Ministry has designated a total of 28 products as rare and urgently needed medical devices, and up to last month, 2,072 products have been supplied to medical institutions.

This content was produced with the assistance of AI translation services.