번호 제목 작성자 날짜 조회수
33 [MDREX Newsletter] MDREX & eCompliance signed MOU MDREX 2024-04-11 10
32 [MDREX Newsletter] Notification from MDREX Regarding the Enactment and Implementation of the Digital Medical Products Act MDREX 2024-04-05 20
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 27
30 [MDREX Newsletter] New Professional Joined! – Senior Advisor Euihyeong Byeon (Reimbursement Expert) MDREX 2024-02-29 29
29 Introduction to the Requirement on Liability Management Measure for Human Implantable Medical Device MDREX 2024-02-06 32
28 Revision on Medical Device Acts: Investigational Device Exemption (IDE) Approval Is to be Exempted for Low-Risk Devices MDREX 2024-02-06 26
27 MDSAP Certificate Holders are to be Exempted from On-Site GMP Inspections (except regular inspections) MDREX 2024-02-06 30
26 The First Provisional Insurance Registration on AI-based SaMD (Innovative Medical Technology Determined) MDREX 2023-12-26 41
25 MFDS Plans to Expand Recognition of Data on Biological Safety MDREX 2023-12-19 43
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 2023-10-20 109
23 [MDREX] Introduction to Korean National Health Insurance Reimbursement System Guidelines for Digital Therapeutics (DTx) at APACMed Webinar MDREX 2023-10-13 92
22 [MDREX] New Professionals Joined! MDREX 2023-09-07 148
21 Announcement of Plans to Apply National Health Insurance Coverage to DTx devices and AI medical devices 관리자 2023-08-12 133
20 [MFDS] Amendment to the Notice of New Category of Medical devices 관리자 2023-07-04 160
19 New Guidelines on addresses of manufacturing sites for KGMP 관리자 2023-06-16 120