FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Japan Plans Breakthrough Designation for Devices

June 7, 2019
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At the recent International Medical Device Regulators Forum (IMDRF) meeting in Moscow, Japanese regulators said they plan to introduce mechanisms to allow for rapid access to needed devices and in vitro diagnostics.

Japan recently adopted its “Sakigake” pathway for breakthrough biologics that allows for provisional approval based on limited clinical data, and it wants to introduce a similar pathway for devices. The new device pathway would need to be approved by legislation.

The proposal would allow for rapid practical use of needed devices  “based on the premise of ensuring safety,” representatives of Japan’s Pharmaceuticals and Medical Devices Agency said. The system would use patient registries or similar electronic tracking to boost postmarket surveillance.

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