[Courtesy of GORE]
SEOUL -- South Korea's drug safety agency will bypass regulations on imports of medical devices to quickly bring in artificial blood vessels for pediatric cardiac surgery through consultations with a U.S. producer.
"In order to prevent the recurrence of medical device supply shortages, we will quickly arrange details on the supply system of rare and urgently needed medical devices," Drug and Food Safety Minister Lee Eui-kyung said Wednesday at a parliamentary committee. She promised to permit imports of rare medical devices even before a new supply system is implemented.
In order to ease a supply shortage, the Seoul government has promised to simplify procedures on imports of medical devices such as artificial blood vessels. The medical division of Gore, which is well known for its outdoor clothing material Gore-Tex, has agreed on an emergency shipment of 20 artificial blood vessels at the request of South Korean health authorities.
Gore's artificial blood vessels or vascular grafts are essential for palliative pediatric cardiac procedures because South Korean hospitals have no alternative for pediatric cardiac surgery.
The American company withdrew from South Korea in October 2017, citing declining profitability due to low health insurance charges and a dispute with the Ministry of Food and Drug Safety, a state watchdog, over manufacturing and quality management standards. Health authorities have introduced new rules.
Lee's office is trying to supply artificial blood vessels through domestic importers after consultations with Gore.
reporter
Lim Chang-won
cwlim34@ajunews.com
