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Australia Medical Device Regulations – a Comprehensive Overview

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

Course description

Australia 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 Australia is utilizing MDSAP.

Training Content


By the end of this course, you should:

  • Understand the Legal and Regulatory Framework for manufacturing, marketing, and distributing medical devices
  • Distinguish how medical devices are classified
  • Understand the Medical Device Single Audit Program (MDSAP) and its function in Australia
  • Understand the premarket pathway(s) and requirements for medical devices
  • Understand the Quality Management System regulations required to market a medical device in Australia
  • Understand the post-market requirements for medical devices

For more information Visit University Website.

Certification / Credits


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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