Korea’s Ministry of Food and Drug Safety (MFDS) recently published final revisions regarding importing non-registered medical devices under special circumstances, including for research and personal use only, scarce or urgently needed, to be used by a Korean laboratory, clinical trials and/or orphan products.
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https://asiaactual.com/wp-content/uploads/2020/03/shutterstock_459822538-scaled.jpg 1707 2560 Bryan Gilburg https://asiaactual.com/wp-content/uploads/2020/08/Growing-Medical-Device-Sales-1030x257.gif Bryan Gilburg2020-03-16 20:28:002020-11-10 12:00:00GUIDANCE ISSUED FOR IMPORTING UNREGISTERED MEDICAL DEVICES INTO KOREA
https://asiaactual.com/wp-content/uploads/2020/06/shutterstock_1505193107-scaled.jpg 1707 2560 Bryan Gilburg https://asiaactual.com/wp-content/uploads/2020/08/Growing-Medical-Device-Sales-1030x257.gif Bryan Gilburg2020-06-10 20:00:492020-11-10 12:00:00HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIES
By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.