EMERGO SUMMARY OF KEY POINTS:

• The South Korean MFDS has updated medical device regulations covering premarket reviews, registrations and enforcement.
• MFDS is also seeking industry comment on a draft proposal updating medical device safety and adverse event reporting requirements.

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.

Changes to MFDS medical device approval, notification and review requirements

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:

• For software-only devices, market applicants do not have to provide preparation and storage information in their submissions
• Updated list of tables for technical documentation requirements to include additional device categories
• For IVDs, quality management testing data may be submitted to MFDS if quality management test reports for final devices are unavailable
• Medical devices under development may qualify for designation as orphan devices; orphan device designation may be cancelled, however, if a device is distributed for a purpose different than to treat or diagnose its designated rare disease or condition

Enforcement Decree of the Medical Devices Act

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:

• Collection, processing and assessment of medical device distribution and Unique Device Identification (UDI) data
• Operating and maintaining the Medical Device Combined Information Center
• Setting up and overseeing standardization of medical device data submitted through the Medical Device Combined Information Center

MFDS has also revised and updated its list of penalties for violating the Medical Devices Act.

Updated safety and adverse event reporting requirements

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:

• A defined process for delivering safety-related notices to device users and handlers
• A more defined process for reporting device safety-related data from overseas markets
• Updated requirements for safety-related document submissions to MFDS
• Criteria related to requesting and qualifying for due date extensions for supplementary data submissions

Additional information on South Korean medical device regulations:

• South Korean MFDS medical device registration consulting
• Korea Good Manufacturing Practice (KGMP) quality management system consulting
• MFDS medical device vigilance reporting consulting and support
• Whitepaper: The South Korean medical device registration process
• Webinar: MFDS medical device and IVD approval