This course provides a comprehensive overview of Australia’s medical device regulatory framework, including both pre-market and post-market requirements.
This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Australia is utilizing MDSAP.
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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