번호 제목 작성자 날짜 조회수
36 MDREX, Implementation of Renewal for Medical Device Product Approval/Certification/Notification by the Ministry of Food and Drug Safety MDREX 2024-06-13 11
35 MDREX, Online seminar on the procedures and case studies for insurance reimbursement of medical devices (SaMD, etc.) in Japan MDREX 2024-05-23 12
34 [MDREX Newsletter] MFDS Approves DTx No. 3 and 4 in Korea MDREX 2024-04-26 17
33 [MDREX Newsletter] MDREX & eCompliance signed MOU MDREX 2024-04-11 26
32 [MDREX Newsletter] Notification from MDREX Regarding the Enactment and Implementation of the Digital Medical Products Act MDREX 2024-04-05 40
31 [MDREX Newsletter] MDREX set to recruit Director Jaehyun Park to be in charge of product approval, reimbursement, etc. for Japanese medical devices MDREX 2024-03-29 48
30 [MDREX Newsletter] New Professional Joined! – Senior Advisor Euihyeong Byeon (Reimbursement Expert) MDREX 2024-02-29 49
29 Introduction to the Requirement on Liability Management Measure for Human Implantable Medical Device MDREX 2024-02-06 51
28 Revision on Medical Device Acts: Investigational Device Exemption (IDE) Approval Is to be Exempted for Low-Risk Devices MDREX 2024-02-06 47
27 MDSAP Certificate Holders are to be Exempted from On-Site GMP Inspections (except regular inspections) MDREX 2024-02-06 48
26 The First Provisional Insurance Registration on AI-based SaMD (Innovative Medical Technology Determined) MDREX 2023-12-26 74
25 MFDS Plans to Expand Recognition of Data on Biological Safety MDREX 2023-12-19 83
24 National Assembly (“NA”) Audit of the Ministry of Health and Welfare (“MOHW”) and Food and Drug Safety (“MFDS”), Expected Digital Medical Device Regulatory Improvements, and Expanding Causality Investigations MDREX 2023-10-20 145
23 [MDREX] Introduction to Korean National Health Insurance Reimbursement System Guidelines for Digital Therapeutics (DTx) at APACMed Webinar MDREX 2023-10-13 124
22 [MDREX] New Professionals Joined! MDREX 2023-09-07 170