Browse > Article
http://dx.doi.org/10.9718/JBER.2022.43.3.153

A Comparative Study on Innovative Medical Device Management Systems in Major Countries  

Lee, Jin Su (Center for Health Industry Policy, Korea Health Industry Development Institute)
Kim, Sukyeong (Center for Health Industry Policy, Korea Health Industry Development Institute)
Publication Information
Journal of Biomedical Engineering Research / v.43, no.3, 2022 , pp. 153-160 More about this Journal
Abstract
As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the innovative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country's management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.
Keywords
innovative medical device; management system; approval process; product diversity;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
1 Lim KM, Song TJ. A Study on Classification and Differential Grade Management for Medical Devices. J Biomed Eng Res. 2018;39(6);268-277.   DOI
2 Innovative medical device technology and standard development status report; National institute of medical device safety information; 2021.
3 https://medtech.pharnaintelligence.informa.com/datasets/us-breakthrough-devices, accessed on Oct, 31, 2021.
4 Park JY. Analysis of US medical device legislation; Issue Brief on Foreign Laws; Korea Legislation Research institute; 2017;43-70.
5 Breakthrough Device Program - Guidance for Industry and Food and Drug Administration Staff; US FDA; 2018.
6 Announcement of the State Food and Drug Administration on Issuing Special review procedures for innovative medical devices (2018. No.33); China SFDA; 2018.
7 Act on Nurturing Medical Devices Industry and Supporting Innovative Medical Devices (Act No.16045), enforcement date 01, May, 2020.
8 Regulations on the Designation of Innovative Medical Device groups (MOHW Notification 2021-2), enforcement date 05, Jan, 2021.
9 A study on the investigation of new medical device classification and management system in major countries; Korea Health Industry Development Institute; 2021.
10 https://ecfr.gov, accessed on Oct, 31, 2021.
11 https://www.nmpa.gov.cn. accessed on Oct, 31, 2021.
12 CMDE Announcement of the review results of the special review procedure for innovative medical devices; 2014-2021.
13 MFDS Announcement of innovative medical devices designation; 2020-2021.
14 Industry analysis and policy research for diagnostic medical devices; Korea Health Industry Development Institute; 2020.