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Key Postmarket Surveillance Considerations for Transitioning to the New EU Medical Device Regulation

Tuesday April 18, 2017 - 11:00AM EDT to 12:00PM EDT

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Entering Italy with Medical Device Coverage: Clarifying Innovative Access Mechanisms

Tuesday April 4, 2017 – 10:00AM EDT to 11:00AM EDT

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FDA MDR Enforcement Actions: Best Practices for Strengthening MedWatch Form Writing and Reporting

Thursday April 20, 2017 – 12:00PM EDT to 1:00PM EDT

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Japanese Healthcare Labeling: Meeting Cultural and Regulatory Expectations by Localizing Translations

1 Hour Video | Tamaki Asada, nlg Japan 

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There is a timeless little secret in the Japanese market. In the Land of the Rising Sun, where consumers believe “Made in Japan” represents the best, it’s advisable for foreign products to masquerade as local, not just by looking nice, but also appearing Japanese.  This presentation will address how a proper and “localized” translation can help foreign products to wear a Japanese “disguise”. We will discuss the readability issues caused by the unique language structure as well as best practices in working with the local offices of International companies. This is how we bridge the gap between US or European-based authoring and marketing teams, local Japanese reviewers and Marketing specialists, and ultimately the end customer.

  • Why “perfect” localization of your translation is needed – cultural gap
  • Regulatory limitations in expressions used in written documents
  • How not to lose global control of localization process involving Japan


Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

  • Labeling
  • Document Control
  • Packaging
  • Quality Assurance
  • Regulatory Affairs



Tamaki Asada joined nlg in 2012 and has helped to establish nlg’s subsidiary office in Japan. Now, as representative manager of nlg Japan, she works closely with local clients. Tamaki holds a BA in policy management from Keio University and an MA in diplomacy from the University of Birmingham.


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