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번호 제목 작성자 날짜 조회수
13 [MDREX Newsletter] A brief for medical device export procedure to Korea. 관리자 2023-04-12 879
12 Notice of partnership between MDREX and RQS 관리자 2023-03-30 647
11 A brief of "requirements for clinical trial data" accepted by the Ministry of Food and Drug Safety ("MFDS", Korea FDA) 관리자 2023-03-22 735
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 2023-03-15 632
9 MFDS(= Korea FDA) recently amended the "Basic Guidelines on the Operation of K-GMP Certification(January 30, 2023)" 관리자 2023-03-08 1046
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 2023-03-01 925
7 MOHW announced the amended "Guidelines on Utilizing Medical Health Data" 관리자 2023-03-01 603
6 MFDS issues clinical assessment guidelines for DTx products aimed at treating depression etc. 관리자 2023-01-31 811
5 [Legislature and Ministry of Health & Welfare] Graded Reimbursement for Non Face-to-Face Treatment 관리자 2023-01-18 505
4 Usability Engineering Report required for all SaMD product license applications starting in 2023 관리자 2023-01-11 504
3 SaMD used for CDSS Approved for National Health Insurance/Reimbursement in Korea 관리자 2023-01-03 516
2 MOHW and HIRA national health insurance registration of "NGS-CDx tests for non-small cell carcinoma" 관리자 2022-12-20 493
1 New MFDS Regulations on Marketing/Advertising of ClinicalTrial Results for Medical Devices 관리자 2022-12-13 506