In Vitro Diagnostic Devices Testing Disease Presence Through Blood and Urine to Receive Customized Approval and Review

A research institute in Germany is conducting PCR tests to determine COVID-19 infection status.<이미지:Yonhap News>

[Asia Economy Reporter Choi Dae-yeol] The In Vitro Diagnostic Medical Device Act, which assesses the risk of in vitro diagnostic medical devices, classifies them by grade, and includes the basis for management measures such as approval and licensing, came into effect on the 1st.

In vitro diagnostics is a method that uses biochemical reactions on specimens collected from the human body, such as blood, sputum, saliva, urine, and feces, to determine whether a disease is present and its severity. Diagnostic kits used for diagnosing COVID-19 are in vitro diagnostic medical devices. They are distinguished from in vivo diagnostics, which use endoscopy, radiology, or ultrasound.

Originally, related content was included in the Medical Device Act, but it was separated and enacted as a standalone law at the end of April last year. The Ministry of Food and Drug Safety stated, "The paradigm is shifting from disease treatment to prevention-centered diagnosis, and unlike general medical devices used directly on the human body, this law reflects the characteristics of in vitro diagnostic medical devices that target specimens such as blood or urine."

The In Vitro Diagnostic Medical Device Act and its subordinate regulations include provisions for classifying grades based on the impact of diagnostic results on public health. The safety management levels are divided into four grades, from Grade 4 to Grade 1, in descending order of risk. Grades are assigned by assessing the potential harm diagnostic results may have on individuals or public health. Grades 3 and 4 require approval, Grade 2 requires certification, and Grade 1 requires notification for management. Approval and certification specifically include analytical performance tests or clinical performance tests to verify product performance.

Additionally, minor changes that have little impact on safety or efficacy must be reported afterward, and prior approval must be obtained for clinical performance tests, with mandatory annual specialized training. For medical institutions or genetic testing laboratories, a next-generation sequencing in vitro diagnostic test certification system is implemented, and in vitro diagnostic medical devices used in certified tests are exempt from the approval process. The Ministry of Food and Drug Safety stated, "By establishing a safety management system suited to the characteristics and operating a system that meets international standards, we can foster the relevant industry and expand new treatment opportunities."

This content was produced with the assistance of AI translation services.