Sep 18, 2017
EMERGO SUMMARY OF KEY POINTS:
The South Korean Ministry of Food and Drug Safety (MFDS) have made updates to two significant medical device regulations that came into force earlier in 2017, and published one draft update as well.
Emergo consultants in Seoul report that MFDS revisions pertain to South Korean regulations on medical device reviews and approvals, Medical Devices Act enforcement decrees, and device safety information and adverse event reporting rules.
First, South Korean regulators have updated their list of minor changes to registered devices that would only require notification to MFDS or the Medical Device Information & Technology Assistance Center (MDITAC). These requirements are now included in MFDS Notification No. 2017-58 (link in Korean), which came into effect in July 2017.
MFDS defines minor changes as those that do not affect device safety or efficacy; changes include:
Third, MDFS has updated the Enforcement Decree of the Medical Devices ACT (Presidential Decree No. 28224) (link in Korean) that came into force in August 2017.
These updates primarily concern the role of MDITAC in South Korea’s medical device registration process. Specific functions now officially delegated to MDITAC include:
MFDS has also revised and updated its list of penalties for violating the Medical Devices Act.
Finally, MFDS has published a draft of revised regulations (link in Korean) on device safety information and adverse event reporting policies in order to clarify compliance expectations of South Korean market registrants. The ministry is currently soliciting comment from industry on these proposals, with likely enforcement coming at a later, as yet undisclosed date.
Among MFDS’s draft changes are:
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: