EMERGO SUMMARY OF KEY POINTS:

• The South Korean Medical Device Information & Technology Assistance Center (MDITAC) is changing its name to the National Institute of Medical Device Safety Information (NIDS).
• Functions and responsibilities of the division remain the same.

Medical Device regulators at the South Korean Ministry of Food and Drug Safety (MFDS) is renaming its office that oversees Unique Device Identification (UDI) and related data management operations effective June 14, 2018.

The office, formerly the Medical Device Information & Technology Assistance Center or MDITAC, will now be called the National Institute of Medical Device Safety Information (NIDS) (link in Korean).

Established in 2017 under the South Korean Medical Devices Act, NIDS manages efforts including:

• Collecting and processing medical device UDI and distribution data
• Running the MFDS Medical Device Combined Information Center
• Managing standardization of device data submitted to the Medical Device Combined Information Center

Related South Korean medical device regulatory information:

• South Korea MFDS medical device registration consulting
• Korea License Holder in-country representation
• Korea Good Manufacturing Practice (KGMP) quality system consulting