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번호 제목 작성자 날짜 조회수
62 [MDREX NEWSLETTER] MDREX Expands Team: Senior Manager, an Expert in IVD and AI-based Diagnostic Software MDREX 2025-05-29 12
61 [MDREX NEWSLETTER] HIRA Issues a Commissioned Study to Develop Improved Listing Process for Health Insurance Reimbursement of Medical Technologies MDREX 2025-05-15 26
60 [MDREX NEWSLETTER] Amendment to Expand the Scope of the Deferred nHTA System – Advance Notice of Rule Revisions by the MOHW and MFDS MDREX 2025-05-12 31
59 Market Entry Considerations, including Product Approval and Reimbursement Listing, etc., Following the MOHW’s Announcement of the 2025 Implementation Plan for the “National Health Insurance Comprehensive Plan” MDREX 2025-04-15 49
58 2025 MFDS Medical Device Policy Briefing Presentation MDREX 2025-04-07 89
57 MDREX at KIMES 2025: Attending the 40th Korea International Medical & Hospital Equipment Exhibition and Key Seminars MDREX 2025-03-25 66
56 MDREX Visits the 11th MEDICAL JAPAN 2025 in Osaka MDREX 2025-03-13 59
55 HIRA Completes Research on Development of Guidelines for Generating Economic Evidence concerning Digital Therapeutics MDREX 2025-03-11 57
54 Announcement of MFDS Guidelines Following the Implementation of the Digital Medical Products Act MDREX 2025-02-06 92
53 Update related to Regulation on Approvals, etc. of Digital Medical Devices MDREX 2025-01-20 87
52 Revision of the Guideline for the Approval & Review of Angioplasty Catheters, Balloon Dilatation MDREX 2025-01-10 96
51 Administrative Notice on the Enforcement Rules for the Digital Medical Products Act MDREX 2024-12-30 105
50 Heartfelt Wishes for Your Continued Success in 2025 MDREX 2024-12-20 86
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 2024-12-04 122
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 2024-11-19 132