【全球认证】一键收藏!韩国国内符合 GLP 规范的医疗器械测试机构清单!
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发布时间:2024-08-22 09:19:20

众所周知,医疗器械在韩国进行注册之前,需要进行一系列的产品检验和临床测试,以获取能被MFDS认可的测试报告,方便推进后续的医疗器械注册流程。

而韩国对于进行医疗器械产品测试的实验室要求非常严格,必须是符合GLP规范且得到MFDS授权的实验室。本篇文章知汇为您介绍一下韩国国内符合GLP规范且具有相应资质的实验室。

以下是韩国国内符合GLP规范且具有相应资质的实验室清单:

(1)Korea Testing and Research Institute, Hwasun 
12-63, Sandan-gil, Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea (Zip code : 58141)
(2)Korea Testing Laboratory
Medical Industry Venture Center, 1397, Bugwon-ro, Heungeop-myeon, Wonju-si, Gangwon State, Korea, (Zip code : 26495)
(3)Nonclinical Research Institute, CORESTEMCHEMON Inc.
240, Nampyeong-ro, Yangji-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Korea(Zip code : 17162)
(4)Daegu-Gyeongbuk Medical Innovation Foundation(DGMIF) Medical Device Development Center
DGMIF Medical Device Development Center, 80, Cheombok-ro, Dong-gu, Daegu, Korea (Zip code :41061)
(5)Korea Conformity Laboratories, Bio Technology Division
8, Gaetbeol-ro 145beon-gil, Yeonsu-gu, Incheon, Korea (Zip code : 21999)
(6)Osong Medical Innovation Foundation
123 Osongsaengmyung-ro, Osong-eub, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea (Zip code : 28160)
(7)Korea Testing Certification Institute, Bio Health Center
57, Yangcheong 3-gil, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Korea (Zip code : 28115)
(8)Korea Testing & Research Institute
Bld #3, 98, Gyoyukwon-ro, Gwacheon-si, Gyeonggi-do, Korea (Zip code : 13810)
(9)DT&CRO CO.,Ltd.
Safety Evaluation Center, Na-dong, 46, Yurim-ro 154beon-gil, Cheoin-gu, Yongin-si, Gyeonggi-do, 17042, Republic of Korea (Zip code : 17042)
(10)Seoul National University Dental Hospital Dental Life Science Research Institute, Dental Materials & Devices Evaluation Center
101, Daehak-ro, Jongno-gu, Seoul, Korea (Zip code : 03080)
(11)Seoul National University Hospital, Biomedical Research Institute
101, Daehak-ro, Jongno-gu, Seoul, Korea (Zip code : 03080)
(12)Korea Research Institute of Chemical Technology, Korea Institute of Toxicology
141, Gajeong-ro, Yuseong-gu, Daejeon, 34114, Republic of Korea (Zip code : 34114)
(13)Gyeongbuk Technopark
Gyeongbuk Technopark Medical Convergence Materials Commercialization Center, 125, Jisiksaneop-ro, Hayang-eup, Gyeongsan-si, Gyeongsangbuk-do, Korea (Zip code : 38408)
(14)Dental Devices Testing and Evaluation Center, Yonsei University Health System
514, ABMRC, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea (Zip code : 03722)
(15)Biomedical Evaluation & Research Center, Chonnam National University R&BD Foundation
33 Yongbong-ro, Yongbong-dong, Buk-gu, Gwangju, Republic of Korea (Zip code : 61186)
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