Japan PMDA Raising Medical Device Registration Fees

On April 1st, 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has raised the registration fees for most medical devices . PMDA fee increase is ranging from 8% to 15% across nine device categories as shown below:

  • Class II and III new devices
  • Class II and III improved devices with clinical data
  • Class II and III generic devices with approval standards
  • Class IV improved devices with clinical data
  • Class IV improved devices without clinical data or approval standards
  • Class IV generic devices without clinical data or approval standards
  • Class IV generic devices with approval standard.

 

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