[{"data":1,"prerenderedAt":230},["ShallowReactive",2],{"content-korean-mdms-en":3},{"id":4,"title":5,"body":6,"description":221,"extension":222,"meta":223,"navigation":225,"path":226,"seo":227,"stem":228,"__hash__":229},"content\u002Fkorean-mdms\u002Fkorean-mdms.en.md","Korean Medical Device Registration (MFDS & MDMS)",{"type":7,"value":8,"toc":200},"minimark",[9,14,18,21,24,28,31,47,50,52,56,59,64,72,76,84,88,96,98,102,105,119,121,125,128,132,140,144,152,156,164,168,176,180,188,190,194,197],[10,11,13],"h2",{"id":12},"medical-device-registration-in-south-korea","Medical Device Registration in South Korea",[15,16,17],"p",{},"To market medical devices or in vitro diagnostic devices in South Korea, manufacturers must obtain approval or registration from the Ministry of Food and Drug Safety (MFDS).",[15,19,20],{},"All regulatory activities, including product registration and lifecycle management, are managed through the Medical Device Management System (MDMS), the official digital platform used by Korean authorities.",[22,23],"hr",{},[10,25,27],{"id":26},"the-mdms-platform","The MDMS Platform",[15,29,30],{},"The Medical Device Management System (MDMS) is the central database for:",[32,33,34,38,41,44],"ul",{},[35,36,37],"li",{},"Device registration and approval",[35,39,40],{},"Submission of technical documentation",[35,42,43],{},"Manufacturer and importer registration",[35,45,46],{},"Post-market updates and reporting",[15,48,49],{},"All applications and regulatory communications with MFDS are processed through MDMS.",[22,51],{},[10,53,55],{"id":54},"regulatory-pathways","Regulatory Pathways",[15,57,58],{},"Depending on device classification, different regulatory routes apply:",[60,61,63],"h3",{"id":62},"class-i-devices","Class I Devices",[32,65,66,69],{},[35,67,68],{},"Notification-based process",[35,70,71],{},"Simplified registration through MDMS",[60,73,75],{"id":74},"class-ii-devices","Class II Devices",[32,77,78,81],{},[35,79,80],{},"Certification by a notified certification body",[35,82,83],{},"Submission through MDMS",[60,85,87],{"id":86},"class-iii-and-iv-devices","Class III and IV Devices",[32,89,90,93],{},[35,91,92],{},"Full MFDS approval required",[35,94,95],{},"Detailed technical documentation and review process",[22,97],{},[10,99,101],{"id":100},"key-requirements","Key Requirements",[15,103,104],{},"To complete registration in Korea, manufacturers must ensure:",[32,106,107,110,113,116],{},[35,108,109],{},"Appointment of a Korea License Holder (KLH)",[35,111,112],{},"Compliance with Korea Good Manufacturing Practice (KGMP)",[35,114,115],{},"Preparation of technical documentation aligned with MFDS requirements",[35,117,118],{},"Submission of all required data through MDMS",[22,120],{},[10,122,124],{"id":123},"our-services","Our Services",[15,126,127],{},"ALTRION supports manufacturers throughout the entire Korean regulatory process, ensuring efficient and compliant interaction with MFDS and MDMS.",[60,129,131],{"id":130},"regulatory-strategy","Regulatory Strategy",[32,133,134,137],{},[35,135,136],{},"Device classification and pathway definition",[35,138,139],{},"Registration planning and timeline optimization",[60,141,143],{"id":142},"mdms-submission","MDMS Submission",[32,145,146,149],{},[35,147,148],{},"Preparation and submission of registration dossiers",[35,150,151],{},"Management of MDMS workflows and documentation",[60,153,155],{"id":154},"kgmp-compliance","KGMP Compliance",[32,157,158,161],{},[35,159,160],{},"Support for KGMP certification",[35,162,163],{},"Audit preparation and coordination",[60,165,167],{"id":166},"regulatory-communication","Regulatory Communication",[32,169,170,173],{},[35,171,172],{},"Liaison with MFDS authorities",[35,174,175],{},"Management of queries and additional information requests",[60,177,179],{"id":178},"post-market-activities","Post-Market Activities",[32,181,182,185],{},[35,183,184],{},"Updates, modifications, and renewals",[35,186,187],{},"Incident reporting and compliance monitoring",[22,189],{},[10,191,193],{"id":192},"our-approach","Our Approach",[15,195,196],{},"We combine local regulatory expertise with international experience to provide a structured and reliable pathway into the Korean market.",[15,198,199],{},"By managing MDMS submissions and regulatory processes directly, we ensure transparency, efficiency, and full compliance throughout the entire product lifecycle.",{"title":201,"searchDepth":202,"depth":202,"links":203},"",2,[204,205,206,212,213,220],{"id":12,"depth":202,"text":13},{"id":26,"depth":202,"text":27},{"id":54,"depth":202,"text":55,"children":207},[208,210,211],{"id":62,"depth":209,"text":63},3,{"id":74,"depth":209,"text":75},{"id":86,"depth":209,"text":87},{"id":100,"depth":202,"text":101},{"id":123,"depth":202,"text":124,"children":214},[215,216,217,218,219],{"id":130,"depth":209,"text":131},{"id":142,"depth":209,"text":143},{"id":154,"depth":209,"text":155},{"id":166,"depth":209,"text":167},{"id":178,"depth":209,"text":179},{"id":192,"depth":202,"text":193},"Full support for MFDS registration and MDMS submission for medical devices entering the Korean market.","md",{"image":224},"\u002Fimages\u002Fmdms.jpg",true,"\u002Fkorean-mdms\u002Fkorean-mdms.en",{"title":5,"description":221},"korean-mdms\u002Fkorean-mdms.en","_EGFd1_88nfFMW9NmOBFqmwyUlZQhus2Y8XCpzVEPC8",1775573784294]