Lab Med Online.  2012 Jul;2(3):148-165.

A Draft Proposal for Korean Classification and Coding System for In Vitro Diagnostic Medical Devices

  • 1Department of Laboratory Medicine, Ajou University School of Medicine, Suwon, Korea.
  • 2Department of Laboratory Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.
  • 3Department of Laboratory Medicine, Korea Institute of Radiological and Medical Sciences, Seoul, Korea.
  • 4Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
  • 5Hanmi Holdings Inc., Seoul, Korea.
  • 6Department of Laboratory Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.


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.
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.
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.
This draft for the Korean IVDD classification and coding system could be used for effective management and regulation of IVDD in Korea.


In vitro diagnostic medical devices (IVDD); Classification; Coding; Risk
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