The Ministry of Food and Drug Safety (MFDS) said Thursday it would obligate medical equipment makers operating in Korea to report all medical incidents and other harmful effects that occur overseas.

The new regulation comes as a measure to heighten safety as the export of domestic medical devices and the number of devices imported from overseas is increasing.

Until now, medical device businesses such as manufacturers and importers only had to reports on medical incidents occurring in Korea. The report is compulsory for both exported and imported medical equipment for any critical incidents such as death and physical disability occurring abroad.

The ministry calls for companies to report within seven days from the date of recognition in life-threatening cases, 15 days for physical disability cases, and 30 days for minor injury cases.

Companies need to directly submit such cases to either the medical device electronic civil service website (http://emed.mfds.go.kr) or fill out and submit the case report by mail or fax.

The ministry has also issued guidelines on the reporting method so that medical device handlers can accurately report problematic cases on its website.

“The new procedure will ensure patient safety with the use of safe medical devices while helping medical companies to develop safer medical devices,” the ministry said. “The government will do our best to provide safe medical devices by collecting, analyzing and evaluating safety information more systematically.”

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