§ INTERACTIVE TOOLS
Japan Registration Pathway Finder
Determine the correct regulatory route for Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in under 60 seconds.
Step 1 / 3
What is your device risk class?
01 / SHONIN
Standard pre-market approval for Class III, IV, and innovative Class II devices. Requires full PMDA scientific review.
02 / NINSHO
Third-party certification for Class II devices with published standards. Faster than Shonin.
03 / TODOKEDE
Simple notification for Class I devices. No PMDA review or clinical data required.