The Ministry of Food and Drug Safety of Korea ("MFDS") stated in its conference for digital health regulatory matters on November 25 of last year that it would start requiring usability engineering report by IEC 62366 for all SaMD product license applications starting in 2023.   The MFDS stated the rationale for this decision is because the need to check whether the UI/UX of a SaMD product meets the physical and mental state of the patient has risen due to the uptick in medical VR and mobile app SaMD products in the market.  Therefore, all product license applications for SaMD products will require the Usability Engineering Report (in Korean language) conducted on Korean nationals to be included in the product license applications to the MFDS.

Please feel free to reach out to us at pro@mdrex.co.kr if you have any questions regarding SaMD or any medical device regulatory related questions for the Korean market.