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KMID : 1137820230440010073
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의공학회지
2023 Volume.44 No. 1 p.73 ~ p.79
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A Study on the Improvement of Domestic Medical Device Product Classification through Analysis of Medical Device Classification System in the U.S. and Europe
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You Kang-Hyeon
Son Ji-Min
Kwon Gyeong-Min
Kim You-Rim
Lee Hui-Sung
Jang Won-Seuk
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Abstract
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The purpose of this study is to derive medical devices with different management systems through com- parison of domestic and overseas medical device product classification systems and to propose management con- version measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety’s regulations on medical device products and grades, 21 CFR part 860-892 and product code clas- sification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification sys- tems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under med- ical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.
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KEYWORD
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Medical device, Classification, Management transition, Drug, Quasi-drug
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