Comprehensive regulatory requirements including the regulatory framework, pre and post market requirements, and instruction on the way Japan is utilizing MDSAP.
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
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NSF International is pleased to offer e-learning Courses (the “Course” or “Courses”) for use through this website on the express condition that you agree to and abide by these terms and conditions (the “Agreement”).
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- Links to Other Websites. A Course may contain links to third party websites. Access to any other website linked to the Course is at the user's own risk and NSF is not responsible for the accuracy or reliability of any information, data, opinions, advice or statements found on those websites, and NSF does not exert any editorial or other control over those other sites. NSF provides these links merely as a convenience to You and the inclusion of such links does not imply an endorsement by NSF of any such third party sites or their content.
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- Entire Agreement. This Agreement, its terms and conditions, as well as such other agreements or documents referenced herein, as each may be amended from time to time, constitute the entire agreement between You and NSF with respect to the subject matter of this Agreement and Your use of the Course, and they supersede all previous communications, representations or agreements, whether oral, written or electronic, between the parties with respect to said subject matter. A printed version of this Agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to the terms and conditions of this Agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form.
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