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번호 제목 작성자 날짜 조회수
52 Revision of the Guideline for the Approval & Review of Angioplasty Catheters, Balloon Dilatation MDREX 2025-01-10 3
51 Administrative Notice on the Enforcement Rules for the Digital Medical Products Act MDREX 2024-12-30 13
50 Heartfelt Wishes for Your Continued Success in 2025 MDREX 2024-12-20 12
49 Procedures for Immediate Entry of the Medical Device Market, Mandatory Registration of Medical Device Contract Sales Organizations (CSO), and the Second Proposed Amendment of the Digital Medical Products Act MDREX 2024-12-04 29
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 30
47 Re-announcement of Enforcement Rules for the Digital Medical Products Act MDREX 2024-11-05 54
46 Regulatory Updates Pertaining to Medical Device Companies Part II MDREX 2024-10-30 62
45 Recent Regulatory Updates Pertaining to Medical Device Companies MDREX 2024-10-22 69
44 MDREX Hosts Seminar on Upcoming Digital Medical Products Act: Implementation Scheduled for January 24, 2025 MDREX 2024-10-14 64
43 MDREX, Co-hosting Online Seminars Focusing on “Considerations in reimbursement listing upon implementation of Digital Medical Products Act” MDREX 2024-09-24 49
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 71
41 MFDS Announces Legislative Notice for Enforcement Decrees and Enforcement Rules of the Digital Medical Products Act MDREX 2024-08-08 131
40 [MDREX Newsletter] MFDS reduces subject with medical device supply history reporting duty… effective from reporting for June MDREX 2024-08-02 129
39 MDREX, Introducing Improvements in Japanese Insurance Regulations for SaMD Products. MDREX 2024-07-24 120
38 MDREX Welcomes Mr. Wonwoo LEE as Vice President (COO) to Support Innovative Medical Device Exports MDREX 2024-07-15 104