Big Event | Qankorey passed KGMP on-site audit
Visits:
22113
2025-01-10
During the four-day KGMP certification audit from 6-9th Jan, 2025, Qankorey successfully passed the on-site audit conducted by KTR, the largest certification body in South Korea, with an outstanding performance of fully meeting all 72 audit clauses, thus laying a solid foundation for entering the South Korean medical market.
The product: One Step Dementia Risk Test Kit
(Colloidal Gold Lateral Immunochromatography) is an in vitro rapid diagnostic reagent for Class II medical devices. For products with a medical device classification level above Class II to enter the South Korean market, it is necessary not only to submit product technical documents and test reports but also to obtain the KGMP certificate. KGMP requires manufacturers to submit product application materials to the third-party auditing institutions authorized by the Ministry of Food and Drug Safety (MFDS) in South Korea to prove that the design, risks, production quality control and other aspects of the devices meet the relevant requirements of the Korea Good Manufacturing Practice (KGMP), and also to accept on-site inspections by qualified third-party auditing institutions or the Ministry of Food and Drug Safety (MFDS).
The institution that carried out this KGMP audit is the Korea Testing and Research Institute (KTR), which is an official professional testing institution of the Ministry of Food and Drug Safety (MFDS) in South Korea and also the most authoritative quality certification body in South Korea. The auditing teachers from South Korea are highly professional and experienced. During the auditing process, the thinking based on medical device risk management ran through all the time. They paid attention to details and were rigorous and practical. From the project intention to cooperation negotiations, from the initial registration planning to the preparation and submission of materials, from the coordination of the KGMP audit schedule to the on-site control of the audit process, colleagues from our company's foreign trade center, quality department and technical department worked in division of labor and cooperated tacitly, and finally passed the KGMP on-site audit smoothly.
All members of Qankorey are very honored for the arrival and work guidance of the KGMP team,we would like to express great respect for the KGMP team's hard work. Moreover, we are very grateful to KGMP for providing constructive advice.
RELATED INFORMATION
Domestic business consulting Tel:+86-731-85714218
E-mail:yingxiao@qankorey.com
Internation Marketing Tel:+86-18874232226
E-mail:lisa@qankorey.com
Company address: 12F, Building 15, No.188 Middle Huanbao Road, Yuhua District, Changsha, Hunan, China 410116
Production Address: 4/F, Building 7, Yuhua Intelligent Manufacturing Center, No.2 Hongda Road, Tongsheng Street, Yuhua District, Changsha,Hunan China,410007
Public Number
Small program
Jingdong
Taobao