South Korea - Proposed Amendments to the “Regulations on In Vitro Diagnostic Medical Device Group and Class by Group”

​The Ministry of Food and Drug Safety (MFDS) is amending the " Regulations on In Vitro Diagnostic Medical Device Group and Class by Group” as follows:

- Establishment of classification criteria for self-testing in vitro diagnostic (IVD) medical devices based on intended use, user, and product features, and other relevant requirements.​