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번호 제목 작성자 날짜 조회수
48 New Administration Pre-Announcements of Proposed Amendments to the Administrative Rules for In Vitro Diagnostic Medical Device Permit and Medical Device Labeling Requirements MDREX 2024-11-19 2
47 Re-announcement of Enforcement Rules for the Digital Medical Products Act MDREX 2024-11-05 17
46 Regulatory Updates Pertaining to Medical Device Companies Part II MDREX 2024-10-30 26
45 Recent Regulatory Updates Pertaining to Medical Device Companies MDREX 2024-10-22 30
44 MDREX Hosts Seminar on Upcoming Digital Medical Products Act: Implementation Scheduled for January 24, 2025 MDREX 2024-10-14 38
43 MDREX, Co-hosting Online Seminars Focusing on “Considerations in reimbursement listing upon implementation of Digital Medical Products Act” MDREX 2024-09-24 25
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 40
41 MFDS Announces Legislative Notice for Enforcement Decrees and Enforcement Rules of the Digital Medical Products Act MDREX 2024-08-08 89
40 [MDREX Newsletter] MFDS reduces subject with medical device supply history reporting duty… effective from reporting for June MDREX 2024-08-02 83
39 MDREX, Introducing Improvements in Japanese Insurance Regulations for SaMD Products. MDREX 2024-07-24 85
38 MDREX Welcomes Mr. Wonwoo LEE as Vice President (COO) to Support Innovative Medical Device Exports MDREX 2024-07-15 72
37 [MDREX Newsletter] Designation Status of Innovative Medical Technologies and Methods for Determining the Maximum Amount for Selective ReimbursementNon-Reimbursement MDREX 2024-06-27 86
36 MDREX, Implementation of Renewal for Medical Device Product Approval/Certification/Notification by the Ministry of Food and Drug Safety MDREX 2024-06-13 152
35 MDREX, Online seminar on the procedures and case studies for insurance reimbursement of medical devices (SaMD, etc.) in Japan MDREX 2024-05-23 96
34 [MDREX Newsletter] MFDS Approves DTx No. 3 and 4 in Korea MDREX 2024-04-26 119