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Japan: Fast-track approval scheme implemented in September 2020

  • Writer: ARQon
    ARQon
  • Feb 5, 2021
  • 1 min read

Updated: Feb 8, 2021

Japan MHLW implemented "Sakigake Shinsa Scheme", also known as the Fast-track Medical Device Approval Scheme. With this scheme in place, designated medical devices will be granted approval in almost twice as fast as before.


A list of conditions is stated in the guidelines.


Source: MHLW.go

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