February 10, 2016
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, 3.1ED
- Annex 2: IEC 60601-1-3 : 2008
- Annex 3: IEC 60601-1-6:2010
- Annex 4: IEC 60601-1-8:2012
- Annex 5: IEC 60601-1-10:2012
- Annex 6: The List of in-vitro diagnostic equipment
- Annex 7: IEC 61010-1:2001
- Annex 8: The List of active implantable medical devices
- Annex 9: ISO 14708-1:2000
Transition dates in the new regulation, 2015-115
| Class 4 | Jan 01, 2016 |
| Class 3 | Jan 01, 2016 |
| Class 2 | Jan 01, 2016 |
| Class 1 | Jul 01, 2016 |
Grace period: Dec 31, 2017
Until Dec 31, 2017, medical device manufacturers can apply the previous regulation, No. 2014-122 for their submission which recognizes IEC 60601-1 3.0 ed.
- Medical devices submitted for new application for medical device registration
- Medical devices which need to be resubmitted for medical device registration due to changes which affect any risks on the safety and effectiveness.
Note, medical devices which have already been approved and registered by MFDS do not need to apply this new regulation (unless device changes affect any risks on the safety and effectiveness).
Although not required until January 1, 2018, companies who want to test devices to 60601-1 3rd ed. with Amendment 1 may do so. MFDS will accept the report when they review the technical file.
The Notification is in Korean and may be viewed through this link: http://www.mfds.go.kr/index.do?mid=686&pageNo=2&seq=10371&cmd=v