The New Korean In Vitro Diagnostic Medical Devices Act 2020

As proposed in April 2019 by the Korean Chair of the Health and Welfare Committee, the Korean In Vitro Diagnostic Medical Devices Act (hereinafter as “Korean In Vitro Act”) intends to, among other things,: “…ensure the safety and quality of in vitro diagnostic medical devices, to strengthen global competitiveness thereof, and furthermore, to contribute to the improvement of public health and the development of vitro diagnostic medical devices, by specifying matters concerning the manufacture, import, management, and support of such devices” (Korean In vitro Act, Purpose). Major Regulations of the Korean In Vitro Act 2020 The Minister of Food and Drug Safety “…shall classify and designate the class of each in vitro diagnostic medical device in conformity with the intended use of each device and differences in their potential risks to individual and/or public health.” If someone intend to manufacture or import in vitro diagnostic medical devices, he or she

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