Korea KC Certification | GCA

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 I...

As the performance evaluation system for In Vitro Diagnostic Medical Devices (IVDs) has come into effect, the Ministry of Food and Drug Safety (MFDS) plans to establish the “ Regulations on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices ” ( Announcement No. 2026-236 ) in order to provide detailed criteria beyond those specified in the relevant regulations. Public comments on the proposed regulations will be accepted until June 4, 2026. Korea MFDS in vitro diagnostic medical devices Definitions Defines the terms used in this regulation for the performance evaluation of In Vitro Diagnostic Medical Devices (IVDs). Standards and Methods Provides for the application of standards and specifications under Article 19 of the Medical Devices Act, Korean Industrial Standards (KS), international standards such as ISO and IEC, and test specifications established at the time of approval or certification of In Vitro Diagnostic Medical Devices (IVDs) as standar...