A stack of paper symbolizing an archive of newsletters on digital health and medical device insights

Newsletter

  1. Home
  2. Newsletter
번호 제목 작성자 날짜 조회수
38 MDREX Welcomes Mr. Wonwoo LEE as Vice President (COO) to Support Innovative Medical Device Exports MDREX 2024-07-15 317
37 [MDREX Newsletter] Designation Status of Innovative Medical Technologies and Methods for Determining the Maximum Amount for Selective ReimbursementNon-Reimbursement MDREX 2024-06-27 369
36 MDREX, Implementation of Renewal for Medical Device Product Approval/Certification/Notification by the Ministry of Food and Drug Safety MDREX 2024-06-13 545
35 MDREX, Online seminar on the procedures and case studies for insurance reimbursement of medical devices (SaMD, etc.) in Japan MDREX 2024-05-23 322
34 [MDREX Newsletter] MFDS Approves DTx No. 3 and 4 in Korea MDREX 2024-04-26 418
33 [MDREX Newsletter] MDREX & eCompliance signed MOU MDREX 2024-04-11 495
32 [MDREX Newsletter] Notification from MDREX Regarding the Enactment and Implementation of the Digital Medical Products Act MDREX 2024-04-05 374
31 [MDREX Newsletter] MDREX set to recruit Director Jaehyun Park to be in charge of product approval, reimbursement, etc. for Japanese medical devices MDREX 2024-03-29 331
30 [MDREX Newsletter] New Professional Joined! – Senior Advisor Euihyeong Byeon (Reimbursement Expert) MDREX 2024-02-29 331
29 Introduction to the Requirement on Liability Management Measure for Human Implantable Medical Device MDREX 2024-02-06 388
28 Revision on Medical Device Acts: Investigational Device Exemption (IDE) Approval Is to be Exempted for Low-Risk Devices MDREX 2024-02-06 366
27 MDSAP Certificate Holders are to be Exempted from On-Site GMP Inspections (except regular inspections) MDREX 2024-02-06 434
26 The First Provisional Insurance Registration on AI-based SaMD (Innovative Medical Technology Determined) MDREX 2023-12-26 389
25 MFDS Plans to Expand Recognition of Data on Biological Safety MDREX 2023-12-19 626
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 2023-10-20 476