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번호 제목 작성자 날짜 조회수
68 [MDREX NEWSLETTER] Establishment and Publication of the Guidelines for Reassessment of Health Technology MDREX 2025-09-11 6
67 [MDREX NEWSLETTER] MFDS Clarifies Scope of Digital Medical/Health Support Devices MDREX 2025-09-09 8
66 [MDREX NEWSLETTER] Korean MFDS Pre-announces Enforcement Rule for the Management of Digital Medical/Health Support Devices (Effective January 1, 2026) MDREX 2025-08-13 25
65 Mandatory Application of ISO/IEC 42001:2023 for KGMP Certification under the Digital Medical Products Act MDREX 2025-07-28 47
64 [MDREX NEWSLETTER] Bigger Office, Bigger Possibilities: MDREX Moves to a New Location! MDREX 2025-07-01 50
63 [MDREX NEWSLETTER] Prospects and implications for Korean digital healthcare industry following inauguration of new president, Jae-myung Lee MDREX 2025-06-20 68
62 [MDREX NEWSLETTER] MDREX Expands Team: Senior Manager, an Expert in IVD and AI-based Diagnostic Software MDREX 2025-05-29 63
61 [MDREX NEWSLETTER] HIRA Issues a Commissioned Study to Develop Improved Listing Process for Health Insurance Reimbursement of Medical Technologies MDREX 2025-05-15 77
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 89
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 2025-04-15 116
58 2025 MFDS Medical Device Policy Briefing Presentation MDREX 2025-04-07 227
57 MDREX at KIMES 2025: Attending the 40th Korea International Medical & Hospital Equipment Exhibition and Key Seminars MDREX 2025-03-25 137
56 MDREX Visits the 11th MEDICAL JAPAN 2025 in Osaka MDREX 2025-03-13 112
55 HIRA Completes Research on Development of Guidelines for Generating Economic Evidence concerning Digital Therapeutics MDREX 2025-03-11 108
54 Announcement of MFDS Guidelines Following the Implementation of the Digital Medical Products Act MDREX 2025-02-06 158