EMERGO SUMMARY OF KEY POINTS:

• A new medical device recall system in South Korea blocks sales of certain devices to consumers if safety issues arise.
• The MFDS Harmful Medical Device Distribution Shutdown System went into effect in March 2017.

The South Korean Ministry of Food and Drug Safety (MFDS) has rolled out a new system for medical devices subject to recalls in the country.

The new MFDS system, called the Harmful Medical Device Distribution Shutdown System (link in Korean), is designed to block transactions of targeted devices at distributors such as large discount and convenience retailers as well as supermarkets once product information is transmitted. The system also covers online and mail-order retailers.

All distribution sites exempt from requirements to obtain Medical Device Distribution Licenses are subject to the new recall system. Examples of medical devices that would fall under the new system in the event of a recall include thermometers, pregnancy test kits, condoms and electronic blood pressure monitors.

More resources for South Korea’s medical device market

• South Korea medical device registration consulting
• South Korea medical device vigilance reporting support
• Regulatory process chart for South Korean medical device registration
• Video overview of MFDS approval process