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번호 제목 작성자 날짜 조회수
30 [MDREX Newsletter] New Professional Joined! – Senior Advisor Euihyeong Byeon (Reimbursement Expert) MDREX 2024-02-29 648
29 Introduction to the Requirement on Liability Management Measure for Human Implantable Medical Device MDREX 2024-02-06 688
28 Revision on Medical Device Acts: Investigational Device Exemption (IDE) Approval Is to be Exempted for Low-Risk Devices MDREX 2024-02-06 766
27 MDSAP Certificate Holders are to be Exempted from On-Site GMP Inspections (except regular inspections) MDREX 2024-02-06 889
26 The First Provisional Insurance Registration on AI-based SaMD (Innovative Medical Technology Determined) MDREX 2023-12-26 681
25 MFDS Plans to Expand Recognition of Data on Biological Safety MDREX 2023-12-19 1232
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 2023-10-20 737
23 [MDREX] Introduction to Korean National Health Insurance Reimbursement System Guidelines for Digital Therapeutics (DTx) at APACMed Webinar MDREX 2023-10-13 1278
22 [MDREX] New Professionals Joined! MDREX 2023-09-07 644
21 Announcement of Plans to Apply National Health Insurance Coverage to DTx devices and AI medical devices 관리자 2023-08-12 676
20 [MFDS] Amendment to the Notice of New Category of Medical devices 관리자 2023-07-04 694
19 New Guidelines on addresses of manufacturing sites for KGMP 관리자 2023-06-16 647
18 Pilot Project on Non-Face to Face Treatment(Telemedicine) Begins June 1, 2023. 관리자 2023-06-06 1937
17 New Legislation on Digital Health Products 관리자 2023-05-29 640
16 MFDS accepts RWE for medical device with 3D printer or digital technology(wearable, big data, AI etc.) 관리자 2023-05-15 1317