Essential medical devices will be designated by next year
By Lee, Hye-Kyung | translator Kim, Jung-Ju
24.03.19 16:15:29
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Digital Medical Products Act enacted in January this year¡¦ to manage clinical use and approval in one step
Expected to speed up clinical prescription by designating digital therapeutic devices as 'innovative medical devices'
The Ministry of Food and Drug Safety is considering establishing a system to designate national essential medical devices. More specifically, the government plans to set a specific scope of medical devices that are essential for healthcare, such as rapid antigen test kits and life support devices that were necessary during COVID-19 but were difficult to supply stably through the market¡¯s function alone.
¡ãNam-hee Lee, Director-General of Medical Device Safety at MFDS
At a briefing with the MFDS¡¯s correspondent journalists briefing, Nam Hee Lee, Director-General of the Pharmaceutical Safety Bureau at MFDS, said, "The need to designate essential medical devices has emerged as with pharmaceuticals amid the COVID-19 crisis. However, no specific scope has been s
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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