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).

Korean Medical Devices Act

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 “…shall obtain permission to engage in such business from the “Minister of Food and Drug Safety” and shall acquire “…permission or certification, or file a notification….” In addition, manufacturers and importers of such devices “…shall mark the devices on their exterior or container with labels.”
  • If an in vitro diagnostic medical device “…was developed for use as a companion to a drug, the examination process for obtaining permission or certification, or filing the notification on the companion device, can be conducted at the same time as the examination for the drug.”
  • If an in vitro diagnostic medical device is used to run a clinical test, the person, who wants to run this clinical test “…shall prepare a clinical test plan, and obtain approval from the clinical performance test review committee established in a clinical performance testing institution…”
  • In the event that a medical institution (Article 3 of the Medical Service Act) or a genetic testing institution (Article 49 of the Bioethics and Safety Act) has designed and developed its own testing system for in vitro diagnosis, and intends to conduct a test as prescribed by an Ordinance of Prime Minister, its clinical testing laboratory shall obtain certification for in vitro diagnostic tests from the minister of food and drug safety. In vitro diagnostic medical devices that are utilized in the institution’s testing system shall be deemed to have secured the requisite permission or certification, or to have had notification filed under this Act, only when they are used within their clinical testing laboratory.”

We shall update the reader when more is known about this Act.

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