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번호 제목 작성자 날짜 조회수
56 MDREX Visits the 11th MEDICAL JAPAN 2025 in Osaka MDREX 2025-03-13 5
55 HIRA Completes Research on Development of Guidelines for Generating Economic Evidence concerning Digital Therapeutics MDREX 2025-03-11 1
54 Announcement of MFDS Guidelines Following the Implementation of the Digital Medical Products Act MDREX 2025-02-06 32
53 Update related to Regulation on Approvals, etc. of Digital Medical Devices MDREX 2025-01-20 30
52 Revision of the Guideline for the Approval & Review of Angioplasty Catheters, Balloon Dilatation MDREX 2025-01-10 30
51 Administrative Notice on the Enforcement Rules for the Digital Medical Products Act MDREX 2024-12-30 47
50 Heartfelt Wishes for Your Continued Success in 2025 MDREX 2024-12-20 34
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 67
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 63
47 Re-announcement of Enforcement Rules for the Digital Medical Products Act MDREX 2024-11-05 143
46 Regulatory Updates Pertaining to Medical Device Companies Part II MDREX 2024-10-30 98
45 Recent Regulatory Updates Pertaining to Medical Device Companies MDREX 2024-10-22 107
44 MDREX Hosts Seminar on Upcoming Digital Medical Products Act: Implementation Scheduled for January 24, 2025 MDREX 2024-10-14 87
43 MDREX, Co-hosting Online Seminars Focusing on “Considerations in reimbursement listing upon implementation of Digital Medical Products Act” MDREX 2024-09-24 75
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 2024-08-26 105