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

Newsletter

번호 제목 작성자 날짜 조회수
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 2025-04-15 601
58 2025 MFDS Medical Device Policy Briefing Presentation MDREX 2025-04-07 815
57 MDREX at KIMES 2025: Attending the 40th Korea International Medical & Hospital Equipment Exhibition and Key Seminars MDREX 2025-03-25 447
56 MDREX Visits the 11th MEDICAL JAPAN 2025 in Osaka MDREX 2025-03-13 321
55 HIRA Completes Research on Development of Guidelines for Generating Economic Evidence concerning Digital Therapeutics MDREX 2025-03-11 438
54 Announcement of MFDS Guidelines Following the Implementation of the Digital Medical Products Act MDREX 2025-02-06 466
53 Update related to Regulation on Approvals, etc. of Digital Medical Devices MDREX 2025-01-20 423
52 Revision of the Guideline for the Approval & Review of Angioplasty Catheters, Balloon Dilatation MDREX 2025-01-10 592
51 Administrative Notice on the Enforcement Rules for the Digital Medical Products Act MDREX 2024-12-30 650
50 Heartfelt Wishes for Your Continued Success in 2025 MDREX 2024-12-20 347
49 Procedures for Immediate Entry of the Medical Device Market, Mandatory Registration of Medical Device Contract Sales Organizations (CSO), and the Second Proposed Amendment of the Digital Medical Products Act MDREX 2024-12-04 909
48 New Administration Pre-Announcements of Proposed Amendments to the Administrative Rules for In Vitro Diagnostic Medical Device Permit and Medical Device Labeling Requirements MDREX 2024-11-19 444
47 Re-announcement of Enforcement Rules for the Digital Medical Products Act MDREX 2024-11-05 2336
46 Regulatory Updates Pertaining to Medical Device Companies Part II MDREX 2024-10-30 534
45 Recent Regulatory Updates Pertaining to Medical Device Companies MDREX 2024-10-22 654