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,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。
上一期文章中,知汇为读者介绍了韩国国内符合GLP规范且具有相应资质的实验室:【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!本期文章知汇将会介绍一下全球范围内符合韩国GLP规范的医疗器械测试机构清单!
部分机构示例:

以下是全球范围内符合韩国GLP规范且具有相应资质的实验室清单:
1. OMIC (Oversea Merchandise Inspection Co.,) USA Inc.
3344 NW Industrial Street Portland, OR 97210, USA
2. OMIC Australia Pty Ltd
302 Arden Street North Melbourne Victoria 3051, Autralia
3. National Authority for Agro-ForestryFishery Quality, Processing and Market Development Center 1(NAFIQPM Center 1)
51 Le Lai street, Ngo Quyen district, Hai Phong city, Vietnam
4. National Authority for Agro-ForestryFishery Quality, Processing and Market Development Center 2(NAFIQPM Center 2)
No. 167-175 Chuong Duong Street, Ngu Hanh Son District, Da Nang City, Vietnam
5. National Authority for Agro-ForestryFishery Quality, Processing and Market Development Center 3(NAFIQPM Center 3)
No. 1105 Le Hong Phong st. Phuoc Long ward, Nha Trang city, Vietnam
6. National Authority for Agro-ForestryFishery Quality, Processing and Market Development Center 4(NAFIQPM Center 4)
Head office: 91 Hai Thuong Lan Ong Street, Ward 10, District 5, Ho Chi Minh City, Viet Nam
Laboratory: 271 To Ngoc Van Street, Linh Dong Ward, Thu Duc City, Ho Chi Minh City, Viet Nam
7. National Authority for Agro-ForestryFishery Quality, Processing and Market Development Center 5(NAFIQPM Center 5)
57 Phan Ngoc Hien Street, ward 6, Ca Mau, Ca Mau Province, Vietnam
8. National Authority for Agro-ForestryFishery Quality, Processing and Market Development Center 6(NAFIQPM Center 6)
No. 386C Cach Mang Thang Tam Street, Bui Huu Nghia Ward, Binh Thuy District, Can Tho City, Vietnam
9. Technology Center of Dalian Customs District
No 60, Changjiang East Road, Dalian, China (Postcode:116001)
10. Animal & Plant & Foodstuffs Inspection Center of Tianjin Customs District
No.51, Second Street, EconomicTechnological Development Area, Tianjin, China
11. Zhejiang Academy of Science and Technology for Inspection & Quarantine
①No.126, Fuchun Road, Hangzhou, Zhejiang, China (Postcode : 310016)
② No.398, Jianshe Sanlu, Xiaoshan District, Hangzhou, Zhejiang, China (Postcode : 311215)
12. Ningbo Customs District Technology Center No.66, Qingyi Road, Hi-Tech District, Ningbo, Zhejiang 315048, China 13. Animal Plant and Food Inspection Center of Nanjing Customs District No.39, Chuangzhi Road, Jianye District, Nanjing, Jiangsu, China(Postcode:210019) 14. Technology Center of Fuzhou Customs District No. 312, Hudong Road. Fuzhou, Fujian, China, (post code: 350001) 15. Xiamen Customs Technology Center No. 2165, Jiangang Road., Haicang District, Xiamen, Fujian, P.R. of China 16. Guangzhou Customs District Technology Center
① 12-14 floor, Tower B, No.66 Huacheng Avenue, Zhujiang Xincheng, Guangzhou (post code:510623), PR of China
② 6-7/F, Chinas’s Commodity Inspection Building, No. 100, Xianlie Middle Road, Yuexiu District, Guangzhou, Guangdong, China 510070
17. Technical Center of Nanning Customs District No.20, Tiqiang Road, Liangqing District, Nanning, Guangxi, China 18. Export Inspection Agency-Kochi 27/1767A, SHIPYARD QUARTERS ROAD, PANAMPILLY NAQAR(SOUTH), KOCHI PIN682036, KERALA, INDIA 19. Export Inspection Agency-Chennai 6F, CMDA Tower 2, 1, Gandhi Irwin Road, Egmore, Chennai-600008, Tamil Nadu State, India 20. Export Inspection Agency-Kolkata 101, Southend Conclave, 1582, Rajdanga Main Rad, Kolkata, India - 700 107 21. Overseas Merchandise Inspection Co. Ltd (OMIC BANGKOK) 12-14 Yen Akas Soi 3, Yen Akas Road, Chongnonsri, Yannawa, Bangkok 10120, Thailand 22. Science and technology research center of China Customs
①No.6, Tianshuiyuan Street, Chaoyang District, Beijing, China
②No.2, Tuqiaoxinqiao, Tongzhou, China
23. Technology Center of Qingdao Customs District
① No.83, Xinyue Road, Qingdao, Shandong, China
② 53, beijing Road, Free trade port area, Qingdao, Shandong, China
24. Comprehensive Technical Service Center of Weifang Customs No. 39, Siping Road, Kuiwen District, Weifang, Shandong, China (Post Code : 261041) 25. Technology Center of Yantai Customs No.66, Beima Road, Yantai, China(Post Code : 264000) 26. Technology Center of Weihai Customs Daqing Road, EDTZ, Weihai, Shandong, China(Post Code : 264205) 27. Changchun Customs Technology Center No.1301, Puyang Street, Changchun, Jilin, China (Post Code :130062) 28. Technical Center of Shenyang Customs No106, Dongbinhe Road, Shenhe District, Shenyang, China 29. Technical Center for Animal & Plant & Food Inspection and Quarantine of Shanghai Customs District No.1208, Minsheng Road, Pudong New Area, Shanghai, China 30. SGS (Thailand) Limited, Laboratory Services 10, 10/1-4 and 12 Soi Rama Ⅲ S.59, Chong Nonsi, Yan Nawa, Bangkok 10120 31. SGS-CSTC Standards Technical Services (Shanghai) Co. Ltd. 3rd Building No. 889, Yi shan Road, Xu-hui District, Shanghai, China 32. Comprehensive Technology & Service Center of Rongcheng Customs No. 597, Shuangshan East Road , Rongcheng, Shandong, China 33. Comprehensive Technical Service Center of Linyi Customs No. 801, Fenghuang Street, Hedong District, Linyi, Shandong, China. 34. Chinese Academy of Inspection and Quarantine-Comprehensive Test Center No.A3, Gaobeidian North Road, Chaoyang District, Beijing, China 35. SGS India Private Limited, Multi laboratory, Chennai, India 28 B/1(SP), 28 B/2(SP), 2nd Main Road, Ambattur Industrial Estate, Chennai-600058, India 36. Integrated Technical Service Center of Donggang Customs No.22, Yinhe Road, Donggang district, Dandong, Liaoning, China 37. FoodChain ID Testing, LLC 4150 Lafayette Center Drive, Suite 600; Chantilly, VA 20151 38. Comprehensive Technical Service Center of Jining Customs No.62, Guanghe Road, Jining, Shandong, China 39. Central Laboratory (Thailand) Co., Ltd. Bangkok branch 2179, Phaholyothin Rd., Lat Yao, Chatuchak, Bangkok 10900, Thailand 40. Central Laboratory (Thailand) Co., Ltd. Samutsakhon branch 23/13 Moo 9, Khokkham, Mueang Samut Sakhon, Samut sakhon, 74000, Thailand 41. Central Laboratory (Thailand) Co., Ltd. Chiangmai branch 164/86 Moo.3, Donkaew, Maerim, Chiangmai 50180, Thailand 42. Central Laboratory (Thailand) Co., Ltd. Songkhla Branch 9/116 Kanchanawanich Rd., Hat Yai, Hay Yai, Songkhla 90110 Thailand 43. Can Tho Branch Laboratory, Intertek Vietnam Ltd. M10-M13, Nam Song Can Tho, Thanh Thuan, Phu Thu Ward, Cai Rang, Can tho city, Vietnam 44. TÜV SÜD Products Testing (Shanghai) Co., Ltd No.1999, Duhui Road, Minhang District, Shanghai, China 45. Agricultural Chemicals Research Institute No.11, Guangming Rd, Wufong, Taichung 41358, Taiwan 46. Eurofins Analytical Laboratories, Inc.(Eurofins Central Analytical Laboratories & Eurofins GeneScan) 2219 Lakeshore Drive, Suite 500 New Orleans, LA 70122, USA 47. SGS Vietnam Ltd.- Food Laboratory
① Lot Ⅲ/21, 19/5 A Street Industrial Group Ⅲ, Tan Binh Industrial Zone Tay Thanh Ward, Tan Phu Dist, Ho Chi Minh City, Vietnam
② Korea-Vietnam incubator Park in Can Tho, 8th Street, Tra Noc 2 industrial Zone, Phuoc Thoi Ward, O Mon District, Can Tho City, Vietnam* * Testing of Veterinary drug residues only
48. GEO-CHEM LABORATORIES PVT. LTD. Pragati Building, Adjacent to Crompton Greaves, Kanjurmarg (East), Mumbai 400042. India 知汇Wiselink CN拥有包括原澳大利亚药品监督管理局局长Dr. Derrick Beech为首席顾问的国际专业团队,秉承源于澳洲、扎根中国、服务世界的精神,信守专业、真诚、开放的核心价值观,致力于为医疗器械、化妆品、食品、保健品和中药制造商提供全球合规认证和临床试验服务。