The revised COVID-19 in vitro diagnostic device guidelines
By Lee, Hye-Kyung | translator Choi HeeYoung
22.07.27 06:17:57
Due to the prolonged COVID-19, the in vitro diagnostic devices of the MFDS and the Korea Food and Drug Safety Evaluation Institute were very busy. Since the outbreak of COVID-19, the export performance of in vitro diagnostic medical devices has increased by 1.5 times, and the degree felt by in vitro diagnostic departments is said to be 10 times. Currently, in vitro diagnostic devices are operated on a small scale with four researchers and five examiners. However, five examiners are reviewing the workload for approval of in vitro medical devices from 800 companies. Jung Ho-sang, head of the in vitro diagnostic device division, said in a briefing to the journalists on the 26th, "Before COVID-19, there were many complaints