[Press Release, May 1, 2020 / unofficial translation'] Management Tailored to In Vitro Diagnostic Devices, such as Diagnostic Agents for COVID-19 - The newly enacted “ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES” is in effect as of May 1st. - □ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) has announced that the “ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES,” which was enacted for the sake of realizing the safe management of in vitro diagnostic(IVD) devices such as COVID-19 diagnostic agents, comes into effect on May 1st. ○ The current paradigm is changing from a focus on treating diseases to a focus on prevention through diagnosis, etc. In line with this shift, by taking into account the specific characteristics of IVD medical devices which test on samples such as blood/urine, etc., differing from general medical devices which are used directly on the human body, - as of April 30 of last year, the regulations on such devices was separated from the “MEDICAL DEVICES ACT” and a separate law has been established. ○ For reference, major developed nations, including the EU, are already operating separate legal systems for IVD medical devices. □ The main content of the “ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES” and subsidiary laws include ▲ a classification of IVDs based on test result’s impact on public health ▲divided management based on a system of tailored approval/certification/notification ▲the reinforcement and expansion of a foundation for clinical performance studies. ○ (Classification of IVD devices) Divided into 4 classes, from 4 to 1 in the order of higher safety management standards coming first - Grades are designated by considering the potential risk to individuals or the public health that the use (diagnostic results) of a medical device has. ○ (Tailored approval/screenings) Divided management takes place, with approval needed for classes 3-4, certification needed for class 2, and notification required for class 1. Permission/certification will involve the actualization of analytical performance trials and clinical performance trials so that the product’s performance can be confirmed. ○ (Simplification of permission for changes) Minor changes which do not affect a product’s safety/effectiveness shall only be subject to follow-up reporting, thereby supporting quick product launches ○ (Expansion of foundation for clinical performance testing) Clinical performance trial institutions are designated at medical institutions, blood centers, medical schools and sample consignment/analysis institutions, etc. - For a clinical performance trial, the approval of a screening committee must be received in advance, and the staff of the clinical performance trial must receive professional training measuring 8 hours or more every year ○ (Introduction certification system for IVD tests) An IVD test certification system for next-generation sequencing is being implemented for medical institutions and gene testing institutions - IVD devices used for certified tests are exempted from permission procedures □ The Ministry of Food and Drug Safety announced that, by preparing a safety management system matching the characteristics of IVD medical devices and operating a system meeting international standards, we can look forward to the fostering of the in vitro diagnostic medical device industry and the expansion of new treatment opportunities. ○ Furthermore, the Ministry of Food and Drug Safety plans to provide an “operational guide regarding the implementation of law on in vitro diagnostic medical devices.” Detailed information can be found on the Ministry of Food and Drug Safety’s website at Law/Materials > Legal Info > Government Official Guidelines/Civil Service Guide (only available in Korean).