A stack of paper symbolizing an archive of newsletters on digital health and medical device insights

Newsletter

  1. Home
  2. Newsletter
번호 제목 작성자 날짜 조회수
78 [MDREX NEWSLETTER] Changes in Medical Device Post-Market Safety Management - Product Issues Without Patient Harm Now Warrant Careful Management MDREX 2026-10-01 20
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 80
76 [MDREX NEWSLETTER] HIRA Publishes Research on Pathways for Insurance Listing of Digital Medical Technologies (AI & DTx) MDREX 2026-07-24 225
75 [MDREX NEWSLETTER ] MDREX Selected to Conduct MFDS Study on “Significant Change Criteria for Medical Devices” MDREX 2026-06-12 253
74 [MDREX NEWSLETTER ] RWE - Based Product Approval Changes Recognized in Korea : A New Opportunity for Regulatory and Reimbursement Strategy MDREX 2026-05-04 362
73 [MDREX NEWSLETTER ] After MFDS Approval, the Real Battle Is Insurance - MDREX Strengthens Team with Former HIRA Expert MDREX 2026-04-15 428
72 [MDREX NEWSLETTER] Korea Launches Immediate Market Entry Program for Medical Technologies MDREX 2026-02-11 719
71 [MDREX NEWSLETTER] Understanding Korea’s New Management Framework for Non-Reimbursable Medical Services in connection with Indemnity Insurance Policies MDREX 2026-01-27 727
70 [MDREX NEWSLETTER] MFDS Announces Operational Guidance on Digital Medical Device Labeling and Guidelines on Clinical Trials Using Digital Technologies MDREX 2026-01-07 1424
69 [MDREX NEWSLETTER] Updates to the Sub-Regulation following Revisions of the Regulations on New Health Technology Assessment (Effective November 18, 2025) MDREX 2025-11-26 515
68 [MDREX NEWSLETTER] Establishment and Publication of the Guidelines for Reassessment of Health Technology MDREX 2025-09-11 853
67 [MDREX NEWSLETTER] MFDS Clarifies Scope of Digital Medical/Health Support Devices MDREX 2025-09-09 1009
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 1202
65 Mandatory Application of ISO/IEC 42001:2023 for KGMP Certification under the Digital Medical Products Act MDREX 2025-07-28 795
64 [MDREX NEWSLETTER] Bigger Office, Bigger Possibilities: MDREX Moves to a New Location! MDREX 2025-07-01 553