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번호 제목 작성자 날짜 조회수
42 Announcement of the Amendment (draft) to the Medical Devices Act on the Scope and Method of Relief for Damages caused by Medical Device Adverse Events. MDREX 2024-08-26 451
41 MFDS Announces Legislative Notice for Enforcement Decrees and Enforcement Rules of the Digital Medical Products Act MDREX 2024-08-08 1653
40 [MDREX Newsletter] MFDS reduces subject with medical device supply history reporting duty… effective from reporting for June MDREX 2024-08-02 629
39 MDREX, Introducing Improvements in Japanese Insurance Regulations for SaMD Products. MDREX 2024-07-24 488
38 MDREX Welcomes Mr. Wonwoo LEE as Vice President (COO) to Support Innovative Medical Device Exports MDREX 2024-07-15 429
37 [MDREX Newsletter] Designation Status of Innovative Medical Technologies and Methods for Determining the Maximum Amount for Selective ReimbursementNon-Reimbursement MDREX 2024-06-27 574
36 MDREX, Implementation of Renewal for Medical Device Product Approval/Certification/Notification by the Ministry of Food and Drug Safety MDREX 2024-06-13 669
35 MDREX, Online seminar on the procedures and case studies for insurance reimbursement of medical devices (SaMD, etc.) in Japan MDREX 2024-05-23 419
34 [MDREX Newsletter] MFDS Approves DTx No. 3 and 4 in Korea MDREX 2024-04-26 668
33 [MDREX Newsletter] MDREX & eCompliance signed MOU MDREX 2024-04-11 622
32 [MDREX Newsletter] Notification from MDREX Regarding the Enactment and Implementation of the Digital Medical Products Act MDREX 2024-04-05 450
31 [MDREX Newsletter] MDREX set to recruit Director Jaehyun Park to be in charge of product approval, reimbursement, etc. for Japanese medical devices MDREX 2024-03-29 409
30 [MDREX Newsletter] New Professional Joined! – Senior Advisor Euihyeong Byeon (Reimbursement Expert) MDREX 2024-02-29 448
29 Introduction to the Requirement on Liability Management Measure for Human Implantable Medical Device MDREX 2024-02-06 499
28 Revision on Medical Device Acts: Investigational Device Exemption (IDE) Approval Is to be Exempted for Low-Risk Devices MDREX 2024-02-06 521