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번호 제목 작성자 날짜 조회수
80 [MDREX NEWSLETTER] KRW 2.6 Trillion Annual Adjustment to Laboratory Test, CT and MRI Fees Confirmed MDREX 2026-10-30 44
79 [MDREX NEWSLETTER] MDREX, MOU Signed with D&A LLC —  Addressing Medical Device Regulatory and Lega MDREX 2026-10-28 58
78 [MDREX NEWSLETTER] Changes in Medical Device Post-Market Safety Management - Product Issues Without Patient Harm Now Warrant Careful Management MDREX 2026-10-01 99
77 [MDREX NEWSLETTER] Government Announces "AI Basic Healthcare Strategy": The Competitive Standard for Medical AI Shifts to "Value in Clinical Practice" MDREX 2026-09-18 156
76 [MDREX NEWSLETTER] HIRA Publishes Research on Pathways for Insurance Listing of Digital Medical Technologies (AI & DTx) MDREX 2026-07-24 322
75 [MDREX NEWSLETTER ] MDREX Selected to Conduct MFDS Study on “Significant Change Criteria for Medical Devices” MDREX 2026-06-12 347
74 [MDREX NEWSLETTER ] RWE - Based Product Approval Changes Recognized in Korea : A New Opportunity for Regulatory and Reimbursement Strategy MDREX 2026-05-04 432
73 [MDREX NEWSLETTER ] After MFDS Approval, the Real Battle Is Insurance - MDREX Strengthens Team with Former HIRA Expert MDREX 2026-04-15 506
72 [MDREX NEWSLETTER] Korea Launches Immediate Market Entry Program for Medical Technologies MDREX 2026-02-11 901
71 [MDREX NEWSLETTER] Understanding Korea’s New Management Framework for Non-Reimbursable Medical Services in connection with Indemnity Insurance Policies MDREX 2026-01-27 813
70 [MDREX NEWSLETTER] MFDS Announces Operational Guidance on Digital Medical Device Labeling and Guidelines on Clinical Trials Using Digital Technologies MDREX 2026-01-07 1535
69 [MDREX NEWSLETTER] Updates to the Sub-Regulation following Revisions of the Regulations on New Health Technology Assessment (Effective November 18, 2025) MDREX 2025-11-26 598
68 [MDREX NEWSLETTER] Establishment and Publication of the Guidelines for Reassessment of Health Technology MDREX 2025-09-11 929
67 [MDREX NEWSLETTER] MFDS Clarifies Scope of Digital Medical/Health Support Devices MDREX 2025-09-09 1090
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 1275