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.
The new regulation (link in Korean) covers compliance for manufacturers and importers. High-risk IVD manufacturers will require business licenses from the MFDS. The awarding of these is subject to applicants having the correct quality control systems, technical documentation and clinical performance test data
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