Korea MFDS Introduces New Self-Testing IVD Categories for Influenza and Drugs of Abuse

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The Ministry of Food and Drug Safety (MFDS) amended the Regulation on IVD Medical Device Items and Item Classification (Notification No. 2026-45) on June 30, 2026, establishing two new categories of self-testing in vitro diagnostic medical devices (IVDs) for influenza and drugs of abuse.



The amendment expands public access to self-testing IVDs by broadening the scope beyond the existing nine self-testing IVD categories, including those for pregnancy, blood glucose, and COVID-19. The newly introduced influenza self-test kit is expected to enable rapid identification of infected individuals during the early stages of infection, helping to reduce disease transmission. In addition, the drugs of abuse self-test kit will allow individuals to quickly determine whether they have been unintentionally exposed to illicit drugs, supporting timely and appropriate responses.

 
The newly established self-testing IVD categories are as follows.

• K05070.01 IVD reagents for self testing of Influenza virus or SARS-CoV-2 using immunological method (Class 3) - Effective June 30, 2026

• K06060.01 IVD reagents for self testing of drugs of abuse (Class 2) - Effective June 30, 2028


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