WATCH NOW: Japan's Medical Device Approval Process

Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this recorded presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, discusses some of the most complex aspects of the Japanese registration process, including:

  • JMDN codes: device classification and predicates
  • Clinical data requirements and PMDA pre-submission meetings
  • Registration routes (Todokede, Ninsho, Shonin)
  • QMS (Ordinance 169) requirements
  • Role of the Marketing Authorization Holder (MAH)
  • Plus more ...

Recorded October 2016

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