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Unit of study_
BMET5992: Regulatory Affairs in the Medical Industry
2026 unit information
Supply of medical devices, diagnostics and related therapeutic products is regulated in most jurisdictions, with sophisticated and complex regulatory regimes in all large economies. These regulations are applied both to manufacturers and designers and to biomedical engineers undertaking device custom manufacture or maintenance in clinical environments. This UoS will explore the different regulatory frameworks in the 'Global Harmonisation Task Force' group of jurisdictions (US, EU, Canada, Japan, Australia), as well as emerging regulatory practices in Asia and South America. Emphasis will be on the commonality of the underlying technical standards and the importance of sophisticated risk management approaches to compliance.
Unit details and rules
Managing faculty or University school:
Engineering
| Study level | Postgraduate |
|---|---|
| Academic unit | Biomedical Engineering |
| Credit points | 6 |
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Prerequisites:
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None |
|---|---|
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Corequisites:
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None |
| Prohibitions:
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AMME4992 or AMME5992 |
| Assumed knowledge:
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MECH3921 or BMET3921 or AMME5921 or BMET5921 and 6 credit points of 1000-level Chemistry and 6 credit points of Biology units |
At the completion of this unit, you should be able to:
- LO1. Explain why medical devices are regulated
- LO2. Retrieve and analyse publicly-accessible regulatory information relating to currently marketed medical devices
- LO3. Classify, interpret and apply instruments relevant to the regulation of medical devices (Regulations, Regulatory Guidance Documents, Standards, and Specifications)
- LO4. Differentiate between conservative and liberal interpretations of medical device regulatory instruments
- LO5. Identify factors that influence the level of acceptable regulatory risk in a given scenario
- LO6. Plan regulatory & quality activities required for developing & marketing a medical device
- LO7. Construct complete, concise, and unambiguous medical device design documentation
- LO8. Assess the risk and impact of exceptions and failures encountered in medical-device design and manufacture, recommend an appropriate disposition, and construct a supporting rationale
- LO9. Assess a medical-device design change and generate a plan of action to ensure regulatory compliance is maintained
- LO10. Assess a change to a medical device regulatory instrument, and generate a plan of action for maintaining compliance
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