Department of Health
Medical Device Control Office


What's New

Renaming Notice of Medical Device Control Office under Department of Health as Medical Device Division (Updated on 2 Oct 2019)

An updated "Frequency Asked Questions" has just been posted (Updated on 20 Sep 2019)

A trial to accept marketing approval obtained from the Ministry of Food and Drug Safety of Korea for listing application of medical devices under the Medical Device Administrative Control System (MDACS) (Updated on 20 Sep 2019)

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Workshop on Application for Listing Class B/C/D In Vitro Diagnostic (IVD) Medical Devices (Cantonese) (15 Jan 2020)
(NOTE: If, on the date of the event, the Tropical Cyclone Signal No. 8 or above or the Rainstorm “BLACK” Warning is issued (or still in effect) at 9:00 am or thereafter, the event will be automatically cancelled.)

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Press Release

Press release: Safety alert on NADAL hCG Pregnancy Test ( 10 Dec 2019 )

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Safety Alerts and Communications

Summary of Safety Alerts (Updated on 17 Jan 2020)

Important Safety Alerts (Updated on 17 Jan 2020)



Last Revision Date : 17 January 2020