South Korea - Proposition of Amendments to the “Regulation on In Vitro Diagnostic Medical Device Group and Class by Group”

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

1) Establishment of new product categories for in vitro diagnostic (IVD) medical devices for self-testing, used for detecting influenza virus, sexually transmitted infections and drugs of abuse.  

2) Reclassification of IVD reagents for the self-testing of SARS-CoV-2 antigens and antibodies, from an intermediate category (K05000) to a subcategory (K0570.01).​