|
KMID : 1137820230440030204
|
|
의공학회지
2023 Volume.44 No. 3 p.204 ~ p.210
|
|
|
A Study on the Analysis and Improvement of Medical Device Standards in Korea
|
|
Kang Yong-Wan
Kim Kyung-Ah
|
|
|
Abstract
|
|
|
|
This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of med- ical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/ machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with inter- national standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant devi- ation from the latest international standards. On the other hand, the level of compliance with international stan- dards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and qual- ity of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.
|
|
|
KEYWORD
|
|
|
Domestic standards, Medical device standards, Korean industrial standards, International standard, Regulatory requirements
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|