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Unit of study_
PHAR7823: Medical Devices: Development and Regulation
2025 unit information
This unit of study will provide students with the knowledge and skills to understand how medical devices are researched, developed and regulated. The unit will cover traditional medical devices, in vitro diagnostics, digital therapeutics and software-as-a-medical-device products. The regulatory requirements for manufacturing, pre-clinical testing, and clinical testing will be discussed. Finally, the unit will examine the regulatory requirements for registration of these types of products.
Unit details and rules
Managing faculty or University school:
Medicine and Health
| Study level | Postgraduate |
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| Academic unit | Pharmacy |
| 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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PCOL5103 |
| Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
- LO1. Explain the major milestones involved in the lifecycle of a medical device product
- LO2. Evaluate and construct data package requirements for the registration of a medical device product in Australia
- LO3. Perform activities associated with the role of the regulatory affairs specialist
- LO4. Integrate knowledge, skills and experience of medical device product development and regulation using reflective practice
Unit availability
This section lists the session, attendance modes and locations the unit is available in. There is a unit outline for each of the unit availabilities, which gives you information about the unit including assessment details and a schedule of weekly activities.
The outline is published 2 weeks before the first day of teaching. You can look at previous outlines for a guide to the details of a unit.
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Modes of attendance (MoA)
This refers to the Mode of attendance (MoA) for the unit as it appears when you’re selecting your units in Sydney Student. Find more information about modes of attendance on our website.
