1.41. Medical Device Regulation Fundamentals
eLearning Course
Written and presented by Gary Burgess, Director and Principal Consultant at Hill Valley Regulatory Consulting, and previously a senior manager at TGA and Australian manufacturers of active implantable medical devices. This is an introductory to intermediate course giving an overview of the key concepts and requirements of the regulation of medical devices and in vitro diagnostics (IVD) in Australia.
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Overview of medical device regulation in Australia
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Definition and qualification as a Medical Device
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Risk classification
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Conformity Assessment Procedures
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Essential Principles for quality, safety and performance
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Post-market reporting requirements
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Registration pathways in Australia
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Supply of unapproved devices
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Advertising medical devices
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Recent and ongoing regulatory updates
Duration: 1.5 hrs
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