South Korea Implements IVD Regulation Amid Renewed COVID-19 Scare

South Korea, one of the first countries to be hit by the spread of COVID-19 from China, has implemented new standalone IVD regulations.

South_Korea_Covid19

South Korea’s In Vitro Diagnostic Medical Device Act, a new standalone IVDs regulation, was implemented by the South Korean Ministry of Food and Drug Safety (MFDS) on 1 May. Diagnostics had previously been covered under medical device regulations. Act 16433, dated 30 April 2019, gives IVDs a separate regulatory code, a move given extra impetus by the COVID-19 crisis.

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