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South Korea Updates: Innovative Device Designations, IVD Act Enforcement

Regulators in South Korea have issued two recent revisions to medical device and in vitro diagnostic (IVD) registration and approval requirements of note for manufacturers.

South Korea MFDS plans several medical device regulatory updates for 2022

August 28, 2022

Regulators in South Korea have issued two recent revisions to medical device and in vitro diagnostic (IVD) registration and approval requirements of note for manufacturers.

Changes to MFDS process for designating innovative devices

First, the South Korean Ministry of Food and Drug Safety (MFDS) has issued a draft revision (link in Korean) to regulations on procedures for designating innovative medical devices. The revision would establish a basis for application periods whereby South Korean market registrants may request designation of their products as innovative devices.

Stakeholder consultations regarding these draft revisions are open until September 13, 2022.

Improving South Korean IVD regulations

Second, the MFDS has proposed amendments (link in Korean) to enforcement regulations related to the country’s IVD Act. The changes would improve and supplement current IVD regulations, specifically regarding clinical performance testing and labeling requirements.

Comments and feedback on the MFDS proposed changes to IVD regulations will be accepted through September 26, 2022.