Path Opens to Waive Post-Market Studies for Rare Medical Devices Already Proven Overseas

Rare-disease medical devices already used and assessed overseas could avoid lengthy post-market studies in South Korea under newly defined rules.

The Ministry of Food and Drug Safety partially revised its regulations on medical-device post-market studies on the 31st. The changes set out specific criteria for devices with overseas use experience and clarify the documents needed to apply for an exemption.

South Korea’s post-market studies for rare medical devices can otherwise run for as long as seven years. The revised framework provides a formal route for eligible devices to be exempted from that requirement.