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Japan Medical Device Regulations – a Comprehensive Overview

NSF International
Training overview
2 hours
From 399 USD
English
Next start date: Inquire for more information - Online

Course description

Japan Medical Device Regulations – a Comprehensive Overview

This course comprehensively covers regulatory requirements including the regulatory framework, pre and post market requirements, and instruction on the way Japan is utilizing MDSAP.

Training Content

Objectives

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

For more information Visit University Website.

Certification / Credits

Certificate

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

About NSF International

NSF International

NSF International

NSF Health Sciences partners with life science companies, big and small, to provide highly customized end-to-end services throughout the product lifecycle. From early development to commercial manufacture and distribution, our expert services will assist you to: Ensure regulatory compliance Implement...


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Contact info

NSF International

789 N. Dixboro Road
48105 Ann Arbor Michigan

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www.nsf.org

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