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Webinar: Understanding Medical Device Regulatory Pathways in China and Japan

July 20, 2017 @ 10:00 am - 11:00 am

The Countries of China and Japan each present their own unique set of challenges pertaining to medical device development. This is especially true for foreign manufacturers as they strive to stay abreast of the quickly changing device regulations and product approval processes in these sometimes tough-to-navigate geographies.

Join NAMSA for a webinar with XTalks on July 20, 2017, as NAMSA regulatory experts Lei Yang, Medical Research Manager (China); and Kei Yoshikawa, Medical Research Manager (Japan), present information that will assist attendees to:

  • Understand the history of medical device regulations in China and Japan
  • Become familiar with the most recent and significant regulatory shifts in China and Japan, such as:
    • New product classifications
    • Updated registration categories
    • The process of category registration, and information on how to successfully prepare for each
    • Device approval processes, including estimated approval periods
  • Identify the best-fit submission framework to reduce development costs and expedite market introduction timelines
  • Understand the licenses that are required to sell and/or manufacture in China and Japan
  • Identify the appropriate development strategy for optimal development results

Time will also be allotted for Q&A


Online Event, OH United States


(419) 666-9455