Medical Device Regulatory Requirements - Japan (2 hours)

1 module



Course Length
120 mins

NSF Medical Devices



A comprehensive overview of Japan's Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to the Japanese market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how Japan is utilizing MDSAP.  Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard.


By the end of this course, you should:

  • Identify the legal and regulatory framework for medical devices in Japan
  • Understand classification of medical devices in Japan
  • Understand the Medical Device Single Audit Program (MDSAP) and its function in Japan
  • Understand the premarket pathway(s) and requirements for medical devices
  • Understand the Quality Management System regulations required to market a medical device
  • Understand the post-market requirements for medical devices and IVDs


By completing/passing this course, you will attain the certificate Medical Device Certificate

Medical Device Regulatory Requirements - Japan
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Added 17 days ago, by Barbara
Added 20 days ago, by Rebecca
Added 21 days ago, by Maurice
Added about 2 months ago, by Katarzyna
Added 5 months ago, by Anonymous
Added 6 months ago, by Katriina
Added 8 months ago, by David
Added 8 months ago, by Emerance
very strange event occurred after my final exam for Japan. The score states 80% although i did not miss any questions. It seems to have retained the score of the last exam.
Added 9 months ago, by Anonymous
Like the Post Market information!
Added 10 months ago, by Kathleen
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