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Newsletter
번호
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34
[MDREX Newsletter] MFDS Approves DTx No. 3 and 4 in Korea
MDREX
2024-04-26
286
33
[MDREX Newsletter] MDREX & eCompliance signed MOU
MDREX
2024-04-11
337
32
[MDREX Newsletter] Notification from MDREX Regarding the Enactment and Implementation of the Digital Medical Products Act
MDREX
2024-04-05
292
31
[MDREX Newsletter] MDREX set to recruit Director Jaehyun Park to be in charge of product approval, reimbursement, etc. for Japanese medical devices
MDREX
2024-03-29
246
30
[MDREX Newsletter] New Professional Joined! – Senior Advisor Euihyeong Byeon (Reimbursement Expert)
MDREX
2024-02-29
248
29
Introduction to the Requirement on Liability Management Measure for Human Implantable Medical Device
MDREX
2024-02-06
299
28
Revision on Medical Device Acts: Investigational Device Exemption (IDE) Approval Is to be Exempted for Low-Risk Devices
MDREX
2024-02-06
277
27
MDSAP Certificate Holders are to be Exempted from On-Site GMP Inspections (except regular inspections)
MDREX
2024-02-06
325
26
The First Provisional Insurance Registration on AI-based SaMD (Innovative Medical Technology Determined)
MDREX
2023-12-26
307
25
MFDS Plans to Expand Recognition of Data on Biological Safety
MDREX
2023-12-19
341
24
National Assembly (“NA”) Audit of the Ministry of Health and Welfare (“MOHW”) and Food and Drug Safety (“MFDS”), Expected Digital Medical Device Regulatory Improvements, and Expanding Causality Investigations
MDREX
2023-10-20
372
23
[MDREX] Introduction to Korean National Health Insurance Reimbursement System Guidelines for Digital Therapeutics (DTx) at APACMed Webinar
MDREX
2023-10-13
483
22
[MDREX] New Professionals Joined!
MDREX
2023-09-07
353
21
Announcement of Plans to Apply National Health Insurance Coverage to DTx devices and AI medical devices
관리자
2023-08-12
386
20
[MFDS] Amendment to the Notice of New Category of Medical devices
관리자
2023-07-04
425
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