language
ENG
arrow_drop_down
KOR
ENG
JPN
Toggle navigation
About US
Product Approval and KGMP
Product Approval
Quality System(KGMP)
Reimbursement
Clinical Consulting
Certificate Holding Service
Expert
Newsletter
Contact
온라인 교육 및 템플릿
로그인
Newsletter
Home
Newsletter
번호
제목
작성자
날짜
조회수
34
[MDREX Newsletter] MFDS Approves DTx No. 3 and 4 in Korea
MDREX
2024-04-26
2
33
[MDREX Newsletter] MDREX & eCompliance signed MOU
MDREX
2024-04-11
11
32
[MDREX Newsletter] Notification from MDREX Regarding the Enactment and Implementation of the Digital Medical Products Act
MDREX
2024-04-05
23
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
30
30
[MDREX Newsletter] New Professional Joined! – Senior Advisor Euihyeong Byeon (Reimbursement Expert)
MDREX
2024-02-29
32
29
Introduction to the Requirement on Liability Management Measure for Human Implantable Medical Device
MDREX
2024-02-06
33
28
Revision on Medical Device Acts: Investigational Device Exemption (IDE) Approval Is to be Exempted for Low-Risk Devices
MDREX
2024-02-06
29
27
MDSAP Certificate Holders are to be Exempted from On-Site GMP Inspections (except regular inspections)
MDREX
2024-02-06
33
26
The First Provisional Insurance Registration on AI-based SaMD (Innovative Medical Technology Determined)
MDREX
2023-12-26
48
25
MFDS Plans to Expand Recognition of Data on Biological Safety
MDREX
2023-12-19
55
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
118
23
[MDREX] Introduction to Korean National Health Insurance Reimbursement System Guidelines for Digital Therapeutics (DTx) at APACMed Webinar
MDREX
2023-10-13
98
22
[MDREX] New Professionals Joined!
MDREX
2023-09-07
149
21
Announcement of Plans to Apply National Health Insurance Coverage to DTx devices and AI medical devices
관리자
2023-08-12
139
20
[MFDS] Amendment to the Notice of New Category of Medical devices
관리자
2023-07-04
171
1
2
3
제목
내용
작성자 이름
검색
×
비밀번호 입력