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。(最新版,更新日期截止2025年4月)
必格外留意传染病的预防,精心呵护自身健康。
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
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 LaboratoryMedical 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 CenterDGMIF Medical Device Development Center, 80, Cheombok-ro, Dong-gu, Daegu, Korea (Zip code :41061)(5)Korea Conformity Laboratories, Bio Technology Division8, Gaetbeol-ro 145beon-gil, Yeonsu-gu, Incheon, Korea (Zip code : 21999)(6)Osong Medical Innovation Foundation123 Osongsaengmyung-ro, Osong-eub, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea (Zip code : 28160)(7)Korea Testing Certification Institute, Bio Health Center57, Yangcheong 3-gil, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Korea (Zip code : 28115)(8)Korea Testing & Research InstituteBld #3, 98, Gyoyukwon-ro, Gwacheon-si, Gyeonggi-do, Korea (Zip code : 13810)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 Center101, Daehak-ro, Jongno-gu, Seoul, Korea (Zip code : 03080)(11)Seoul National University Hospital, Biomedical Research Institute101, Daehak-ro, Jongno-gu, Seoul, Korea (Zip code : 03080)(12)Korea Research Institute of Chemical Technology, Korea Institute of Toxicology141, Gajeong-ro, Yuseong-gu, Daejeon, 34114, Republic of Korea (Zip code : 34114)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 System514, ABMRC, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea (Zip code : 03722)(15)Biomedical Evaluation & Research Center, Chonnam National University R&BD Foundation33 Yongbong-ro, Yongbong-dong, Buk-gu, Gwangju, Republic of Korea (Zip code : 61186)(16)Division of Jeonbuk Advanced Bio Research, Korea Institute of Toxicology30, Baekhak 1-gil, Jeongeup-si, Jeollabuk-do, Republic of Korea (Zip code : 56212)53, Yeongudanji-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea (Zip code : 28115)3-301, 120 Gunpocheomdansaneop-2ro, Gunpo-si, Gyeonggi-do, Korea (Zip code : 15880)如果您想了解更多相关内容,欢迎来Wiselink公众号私信获取相关pdf文件!