Global Medical Device Regulatory Requirements – Japan (2 hours)
5
What you'll gain from this course
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Interactive modules and knowledge checks
Certificate available upon completion
This two-hour course provides a comprehensive overview of regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way Japan is utilizing MDSAP.
Key learning objectives
By the end of this course, you will be able to:
- 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 pre-market pathway(s) and requirements for medical devices in Japan
- Understand the quality management system regulations required to market a medical device in Japan
- Understand the post-market requirements for medical devices and IVDs in Japan
This course is essential for anyone wanting to bring a medical device or IVD to market in Japan, and also for employees in R&D, regulatory, quality and compliance functions.
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