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。
本篇文章知汇将为您介绍符合韩国GLP标准的医疗器械测试机构名单,涵盖韩国本土及海外两部分测试机构!
韩国本土

全球范围内(不包括韩国本土)

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