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번호 제목 작성자 날짜 조회수
34 [MDREX Newsletter] MFDS Approves DTx No. 3 and 4 in Korea MDREX 2024-04-26 296
33 [MDREX Newsletter] MDREX & eCompliance signed MOU MDREX 2024-04-11 349
32 [MDREX Newsletter] Notification from MDREX Regarding the Enactment and Implementation of the Digital Medical Products Act MDREX 2024-04-05 298
31 [MDREX Newsletter] MDREX set to recruit Director Jaehyun Park to be in charge of product approval, reimbursement, etc. for Japanese medical devices MDREX 2024-03-29 252
30 [MDREX Newsletter] New Professional Joined! – Senior Advisor Euihyeong Byeon (Reimbursement Expert) MDREX 2024-02-29 252
29 Introduction to the Requirement on Liability Management Measure for Human Implantable Medical Device MDREX 2024-02-06 306
28 Revision on Medical Device Acts: Investigational Device Exemption (IDE) Approval Is to be Exempted for Low-Risk Devices MDREX 2024-02-06 282
27 MDSAP Certificate Holders are to be Exempted from On-Site GMP Inspections (except regular inspections) MDREX 2024-02-06 338
26 The First Provisional Insurance Registration on AI-based SaMD (Innovative Medical Technology Determined) MDREX 2023-12-26 313
25 MFDS Plans to Expand Recognition of Data on Biological Safety MDREX 2023-12-19 359
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 2023-10-20 377
23 [MDREX] Introduction to Korean National Health Insurance Reimbursement System Guidelines for Digital Therapeutics (DTx) at APACMed Webinar MDREX 2023-10-13 492
22 [MDREX] New Professionals Joined! MDREX 2023-09-07 360
21 Announcement of Plans to Apply National Health Insurance Coverage to DTx devices and AI medical devices 관리자 2023-08-12 389
20 [MFDS] Amendment to the Notice of New Category of Medical devices 관리자 2023-07-04 429