Korea MFDS announces transition dates for IEC 60601 3rd ed. with Am. 1
On December 31, 2015 the Korea Ministry of Food and Drug Safety (MFDS) issued Notification No. 2015-115 announcing its revision to the medical device regulations for the transition to IEC 60601-1 Third Edition with Amendment 1. According to UL’s regulatory experts in Korea, this regulation includes a total of 9 annexes and merges 7 kinds of international standards: Annex 1: IEC 60601-1:2012,… read more