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번호 제목 작성자 날짜 조회수
55 HIRA Completes Research on Development of Guidelines for Generating Economic Evidence concerning Digital Therapeutics MDREX 2025-03-11 213
54 Announcement of MFDS Guidelines Following the Implementation of the Digital Medical Products Act MDREX 2025-02-06 296
53 Update related to Regulation on Approvals, etc. of Digital Medical Devices MDREX 2025-01-20 228
52 Revision of the Guideline for the Approval & Review of Angioplasty Catheters, Balloon Dilatation MDREX 2025-01-10 329
51 Administrative Notice on the Enforcement Rules for the Digital Medical Products Act MDREX 2024-12-30 236
50 Heartfelt Wishes for Your Continued Success in 2025 MDREX 2024-12-20 197
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 2024-12-04 526
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 2024-11-19 271
47 Re-announcement of Enforcement Rules for the Digital Medical Products Act MDREX 2024-11-05 1421
46 Regulatory Updates Pertaining to Medical Device Companies Part II MDREX 2024-10-30 320
45 Recent Regulatory Updates Pertaining to Medical Device Companies MDREX 2024-10-22 447
44 MDREX Hosts Seminar on Upcoming Digital Medical Products Act: Implementation Scheduled for January 24, 2025 MDREX 2024-10-14 280
43 MDREX, Co-hosting Online Seminars Focusing on “Considerations in reimbursement listing upon implementation of Digital Medical Products Act” MDREX 2024-09-24 264
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 2024-08-26 364
41 MFDS Announces Legislative Notice for Enforcement Decrees and Enforcement Rules of the Digital Medical Products Act MDREX 2024-08-08 1418