MFDS "Improvement of Manufacturing and Quality Control Inspection for Export Medical Devices"

The Ministry of Food and Drug Safety announced on the 12th that it will implement a revised "Medical Device Manufacturing and Quality Control Standards," which changes the conformity assessment for export medical devices from a joint public-private review conducted by regional food and drug offices and quality control review agencies to a review conducted solely by the review agencies.

Through this revision, the actual review processing period for export medical devices will be shortened by 15 days, which is expected to help expedite the export of domestic medical devices.

The Ministry of Food and Drug Safety stated, "We will continue to actively improve the inconveniences and burdens faced by the medical device industry and strengthen the medical device manufacturing and quality control standards system," adding, "We will continuously prepare and implement support measures to increase exports of competitive 'K-Medical Devices.'"