Korean Ministry of Food and Drug Safety (MFDS) recently released a revision of its reference standard as per Ministry of Food and Drug Safety Notice No. 2014-122 affecting South Korea medical device registration.
The purpose is to align with international standards related to electrical and mechanical safety. Are covered the following: radiation safety, usability, alarm system, physiologic closed-loop control, in-vitro diagnostic equipment, active implantable medical devices.
Therefore the following related standards will be applicable for the above topics:
- IEC 60601-1-3 – radiation safety
- IEC 60601-1-6 – usability
- IEC 60601-1-8 – alarm systems
- IEC 60601-1-10 – physiologic closed-loop control
- IEC 61010-1 – Safety Requirements of the electric equipment for measurement, control and test-use
- ISO 14708-1 – General Requirements for safety, display and information to be disclosed by the manufacturer of the active implantable medical devices
This should not be a big issue for foreign manufacturers exporting to Korea since they usually already comply with those standards.