Newsletter

 
번호 제목 작성자 날짜 조회수
18 Pilot Project on Non-Face to Face Treatment(Telemedicine) Begins June 1, 2023. 관리자 2023-06-06 120
17 New Legislation on Digital Health Products 관리자 2023-05-29 117
16 MFDS accepts RWE for medical device with 3D printer or digital technology(wearable, big data, AI etc.) 관리자 2023-05-15 110
15 SaMD products that identify type of cerebral stroke utilizing MR images designated as "innovative medical technology" 관리자 2023-05-10 98
14 2023 Medical Device Expenditure Report Audit Plans by the MOHW 관리자 2023-04-25 123
13 [MDREX Newsletter] A brief for medical device export procedure to Korea. 관리자 2023-04-12 151
12 Notice of partnership between MDREX and RQS 관리자 2023-03-30 134
11 A brief of "requirements for clinical trial data" accepted by the Ministry of Food and Drug Safety ("MFDS", Korea FDA) 관리자 2023-03-22 110
10 A brief outline below on the key questions that are raised when determining whether a product is a medical device as well as the administrative procedures for submitting a written inquiry 관리자 2023-03-15 126
9 MFDS(= Korea FDA) recently amended the "Basic Guidelines on the Operation of K-GMP Certification(January 30, 2023)" 관리자 2023-03-08 106
8 Liability insurance coverage for implantable medical devices (i.e., products that last more than 30 days in the body) has become mandatory as of January 20, 2023 관리자 2023-03-01 95
7 MOHW announced the amended "Guidelines on Utilizing Medical Health Data" 관리자 2023-03-01 111
6 MFDS issues clinical assessment guidelines for DTx products aimed at treating depression etc. 관리자 2023-01-31 127
5 [Legislature and Ministry of Health & Welfare] Graded Reimbursement for Non Face-to-Face Treatment 관리자 2023-01-18 119
4 Usability Engineering Report required for all SaMD product license applications starting in 2023 관리자 2023-01-11 108