Snapshot

The Fast Track and Conditional Fast Track Review for Medical Devices and IVDs pathway has been developed by the of Japan.

This pathway can be used where "Pioneering device” designation => expedited review for devices/IVDs with novel technologies for serious or life-threatening conditions Pre-submission consultation mandatory Review timeframes targeted at 6 months for pioneering devices. Conditional fast-track applies when clinical data is limited due to rarity but safety is supported; requires post-market surveillance. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is .