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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 2024-11-19 671
47 Re-announcement of Enforcement Rules for the Digital Medical Products Act MDREX 2024-11-05 2781
46 Regulatory Updates Pertaining to Medical Device Companies Part II MDREX 2024-10-30 800
45 Recent Regulatory Updates Pertaining to Medical Device Companies MDREX 2024-10-22 907
44 MDREX Hosts Seminar on Upcoming Digital Medical Products Act: Implementation Scheduled for January 24, 2025 MDREX 2024-10-14 651
43 MDREX, Co-hosting Online Seminars Focusing on “Considerations in reimbursement listing upon implementation of Digital Medical Products Act” MDREX 2024-09-24 606
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 2024-08-26 946
41 MFDS Announces Legislative Notice for Enforcement Decrees and Enforcement Rules of the Digital Medical Products Act MDREX 2024-08-08 2212
40 [MDREX Newsletter] MFDS reduces subject with medical device supply history reporting duty… effective from reporting for June MDREX 2024-08-02 1007
39 MDREX, Introducing Improvements in Japanese Insurance Regulations for SaMD Products. MDREX 2024-07-24 998
38 MDREX Welcomes Mr. Wonwoo LEE as Vice President (COO) to Support Innovative Medical Device Exports MDREX 2024-07-15 802
37 [MDREX Newsletter] Designation Status of Innovative Medical Technologies and Methods for Determining the Maximum Amount for Selective ReimbursementNon-Reimbursement MDREX 2024-06-27 1006
36 MDREX, Implementation of Renewal for Medical Device Product Approval/Certification/Notification by the Ministry of Food and Drug Safety MDREX 2024-06-13 1078
35 MDREX, Online seminar on the procedures and case studies for insurance reimbursement of medical devices (SaMD, etc.) in Japan MDREX 2024-05-23 756
34 [MDREX Newsletter] MFDS Approves DTx No. 3 and 4 in Korea MDREX 2024-04-26 1210