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번호 제목 작성자 날짜 조회수
65 Mandatory Application of ISO/IEC 42001:2023 for KGMP Certification under the Digital Medical Products Act MDREX 2025-07-28 6
64 [MDREX NEWSLETTER] Bigger Office, Bigger Possibilities: MDREX Moves to a New Location! MDREX 2025-07-01 14
63 [MDREX NEWSLETTER] Prospects and implications for Korean digital healthcare industry following inauguration of new president, Jae-myung Lee MDREX 2025-06-20 22
62 [MDREX NEWSLETTER] MDREX Expands Team: Senior Manager, an Expert in IVD and AI-based Diagnostic Software MDREX 2025-05-29 30
61 [MDREX NEWSLETTER] HIRA Issues a Commissioned Study to Develop Improved Listing Process for Health Insurance Reimbursement of Medical Technologies MDREX 2025-05-15 44
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 53
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 79
58 2025 MFDS Medical Device Policy Briefing Presentation MDREX 2025-04-07 175
57 MDREX at KIMES 2025: Attending the 40th Korea International Medical & Hospital Equipment Exhibition and Key Seminars MDREX 2025-03-25 99
56 MDREX Visits the 11th MEDICAL JAPAN 2025 in Osaka MDREX 2025-03-13 79
55 HIRA Completes Research on Development of Guidelines for Generating Economic Evidence concerning Digital Therapeutics MDREX 2025-03-11 78
54 Announcement of MFDS Guidelines Following the Implementation of the Digital Medical Products Act MDREX 2025-02-06 112
53 Update related to Regulation on Approvals, etc. of Digital Medical Devices MDREX 2025-01-20 109
52 Revision of the Guideline for the Approval & Review of Angioplasty Catheters, Balloon Dilatation MDREX 2025-01-10 146
51 Administrative Notice on the Enforcement Rules for the Digital Medical Products Act MDREX 2024-12-30 125