South Korea: Revision of the Medical Device Regulations

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 another draft update.

The 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), which came into effect in July 2017.

Additionally, the MFDS has  updated the Enforcement Decree of the Medical Devices Act, which concerns the role of MDITAC in South Korea’s medical device registration process and came into force in August 2017.

Finally, the MFDS has published a draft of revised regulations on device safety information and adverse event reporting policies in order to clarify compliance expectations of South Korean market registrants.

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