A comprehensive overview of Australia's Medical Device regulatory framework, including both Premarket AND Postmarket requirements. Learn what it takes to bring a product to the Australian market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how Australia 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:
- 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
By completing/passing this course, you will attain the certificate Medical Device Certificate
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