한국형 체외진단제품 품목 및 등급분류 체계 제안

Abstract

Background: The Global harmonization task force (GHTF) recommends a separate regulation system for in vitro diagnostic medical devices (IVDD),because false test results can pose a risk to individual and/or public health. However, in Korea, many reagents for IVDD are not monitored, although IVD analyzers and some reagents are monitored under the Medical Device Act and Pharmaceutical Affairs Act, respectively. Our aim was to propose a draft for a Korean coding and classification system for IVDD. Methods: For preparing the draft, we reviewed the Korean Current Procedural Terminology for Health Insurance and principles of the coding and classification system for IVDD of the GHTF, the USA, Japan, Canada, Australia, and the EU. The draft was reviewed by consultants from relevant societies, such as Korean Medical Association, Korean Society for Laboratory Medicine, The Korea Association of Medical Technologists, and Korea Association for Diagnostic Laboratory Reagents, and was then publicly discussed at a conference. Results: IVDD were classified into 4 classes on the basis of the risks they pose to individual (IR) and public health (PR): class 1 (low IR and low PR), class 2 (moderate IR and low PR), class 3 (high IR and/or moderate PR), and class 4 (high IR and high PR). IVD analyzers, reagents and other general laboratory equipments were categorized and coded using the letter D and 7 (2+3+2) digits. Conclusions: This draft for the Korean IVDD classification and coding system could be used for effective management and regulation of IVDD in Korea.