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번호 제목 작성자 날짜 조회수
75 [MDREX NEWSLETTER ] MDREX Selected to Conduct MFDS Study on “Significant Change Criteria for Medical Devices” MDREX 2026-06-12 30
74 [MDREX NEWSLETTER ] RWE - Based Product Approval Changes Recognized in Korea : A New Opportunity for Regulatory and Reimbursement Strategy MDREX 2026-05-04 161
73 [MDREX NEWSLETTER ] After MFDS Approval, the Real Battle Is Insurance - MDREX Strengthens Team with Former HIRA Expert MDREX 2026-04-15 216
72 [MDREX NEWSLETTER] Korea Launches Immediate Market Entry Program for Medical Technologies MDREX 2026-02-11 458
71 [MDREX NEWSLETTER] Understanding Korea’s New Management Framework for Non-Reimbursable Medical Services in connection with Indemnity Insurance Policies MDREX 2026-01-27 373
70 [MDREX NEWSLETTER] MFDS Announces Operational Guidance on Digital Medical Device Labeling and Guidelines on Clinical Trials Using Digital Technologies MDREX 2026-01-07 1120
69 [MDREX NEWSLETTER] Updates to the Sub-Regulation following Revisions of the Regulations on New Health Technology Assessment (Effective November 18, 2025) MDREX 2025-11-26 322
68 [MDREX NEWSLETTER] Establishment and Publication of the Guidelines for Reassessment of Health Technology MDREX 2025-09-11 533
67 [MDREX NEWSLETTER] MFDS Clarifies Scope of Digital Medical/Health Support Devices MDREX 2025-09-09 790
66 [MDREX NEWSLETTER] Korean MFDS Pre-announces Enforcement Rule for the Management of Digital Medical/Health Support Devices (Effective January 1, 2026) MDREX 2025-08-13 988
65 Mandatory Application of ISO/IEC 42001:2023 for KGMP Certification under the Digital Medical Products Act MDREX 2025-07-28 563
64 [MDREX NEWSLETTER] Bigger Office, Bigger Possibilities: MDREX Moves to a New Location! MDREX 2025-07-01 347
63 [MDREX NEWSLETTER] Prospects and implications for Korean digital healthcare industry following inauguration of new president, Jae-myung Lee MDREX 2025-06-20 509
62 [MDREX NEWSLETTER] MDREX Expands Team: Senior Manager, an Expert in IVD and AI-based Diagnostic Software MDREX 2025-05-29 350
61 [MDREX NEWSLETTER] HIRA Issues a Commissioned Study to Develop Improved Listing Process for Health Insurance Reimbursement of Medical Technologies MDREX 2025-05-15 462