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번호 제목 작성자 날짜 조회수
74 [MDREX NEWSLETTER ] RWE - Based Product Approval Changes Recognized in Korea : A New Opportunity for Regulatory and Reimbursement Strategy MDREX 2026-05-04 54
73 [MDREX NEWSLETTER ] After MFDS Approval, the Real Battle Is Insurance - MDREX Strengthens Team with Former HIRA Expert MDREX 2026-04-15 119
72 [MDREX NEWSLETTER] Korea Launches Immediate Market Entry Program for Medical Technologies MDREX 2026-02-11 277
71 [MDREX NEWSLETTER] Understanding Korea’s New Management Framework for Non-Reimbursable Medical Services in connection with Indemnity Insurance Policies MDREX 2026-01-27 258
70 [MDREX NEWSLETTER] MFDS Announces Operational Guidance on Digital Medical Device Labeling and Guidelines on Clinical Trials Using Digital Technologies MDREX 2026-01-07 828
69 [MDREX NEWSLETTER] Updates to the Sub-Regulation following Revisions of the Regulations on New Health Technology Assessment (Effective November 18, 2025) MDREX 2025-11-26 247
68 [MDREX NEWSLETTER] Establishment and Publication of the Guidelines for Reassessment of Health Technology MDREX 2025-09-11 335
67 [MDREX NEWSLETTER] MFDS Clarifies Scope of Digital Medical/Health Support Devices MDREX 2025-09-09 633
66 [MDREX NEWSLETTER] Korean MFDS Pre-announces Enforcement Rule for the Management of Digital Medical/Health Support Devices (Effective January 1, 2026) MDREX 2025-08-13 890
65 Mandatory Application of ISO/IEC 42001:2023 for KGMP Certification under the Digital Medical Products Act MDREX 2025-07-28 394
64 [MDREX NEWSLETTER] Bigger Office, Bigger Possibilities: MDREX Moves to a New Location! MDREX 2025-07-01 255
63 [MDREX NEWSLETTER] Prospects and implications for Korean digital healthcare industry following inauguration of new president, Jae-myung Lee MDREX 2025-06-20 423
62 [MDREX NEWSLETTER] MDREX Expands Team: Senior Manager, an Expert in IVD and AI-based Diagnostic Software MDREX 2025-05-29 276
61 [MDREX NEWSLETTER] HIRA Issues a Commissioned Study to Develop Improved Listing Process for Health Insurance Reimbursement of Medical Technologies MDREX 2025-05-15 361
60 [MDREX NEWSLETTER] Amendment to Expand the Scope of the Deferred nHTA System – Advance Notice of Rule Revisions by the MOHW and MFDS MDREX 2025-05-12 401