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
16 MFDS accepts RWE for medical device with 3D printer or digital technology(wearable, big data, AI etc.) 관리자 2023-05-15 1403
15 SaMD products that identify type of cerebral stroke utilizing MR images designated as "innovative medical technology" 관리자 2023-05-10 631
14 2023 Medical Device Expenditure Report Audit Plans by the MOHW 관리자 2023-04-25 683
13 [MDREX Newsletter] A brief for medical device export procedure to Korea. 관리자 2023-04-12 1096
12 Notice of partnership between MDREX and RQS 관리자 2023-03-30 822
11 A brief of "requirements for clinical trial data" accepted by the Ministry of Food and Drug Safety ("MFDS", Korea FDA) 관리자 2023-03-22 994
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 2023-03-15 811
9 MFDS(= Korea FDA) recently amended the "Basic Guidelines on the Operation of K-GMP Certification(January 30, 2023)" 관리자 2023-03-08 1333
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 1171
7 MOHW announced the amended "Guidelines on Utilizing Medical Health Data" 관리자 2023-03-01 789
6 MFDS issues clinical assessment guidelines for DTx products aimed at treating depression etc. 관리자 2023-01-31 1080
5 [Legislature and Ministry of Health & Welfare] Graded Reimbursement for Non Face-to-Face Treatment 관리자 2023-01-18 640
4 Usability Engineering Report required for all SaMD product license applications starting in 2023 관리자 2023-01-11 655
3 SaMD used for CDSS Approved for National Health Insurance/Reimbursement in Korea 관리자 2023-01-03 705
2 MOHW and HIRA national health insurance registration of "NGS-CDx tests for non-small cell carcinoma" 관리자 2022-12-20 641