Outline

Overview

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

Academic unit	Biomedical Engineering
Credit points	6
Prerequisites ?	None
Corequisites ?	None
Prohibitions ?	AMME4992 or AMME5992
Assumed knowledge ?	MECH3921 or BMET3921 or AMME5921 or BMET5921 and 6 credit points of 1000-level Chemistry and 6 credit points of Biology units
Available to study abroad and exchange students	Yes

Teaching staff

Coordinator	Gurvinder Singh, gurvinder.singh@sydney.edu.au

Assessment

The census date for this unit availability is 31 August 2026

Details
Criteria

Type	Description	Weight	Due	Length	Use of AI
Written exam	Final Exam A written exam will take place during the formal exam period at the end of the semester covering content from week 1 to week 13.	40%	Formal exam period	2 hours	AI prohibited
Outcomes assessed:
Written work	Written Assignment Part 1 Each student will develop an individual assignment on an assigned marketed medical device, progressively refined through tutorial discussion and feedback, followed by submission of a written report based on weeks 2-5.	20%	Week 06 Due date: 07 Sep 2026 at 23:59 Closing date: 07 Sep 2026	7 pages	AI allowed
Outcomes assessed:
Written work	Written Assignment Part 2 Each student will develop an individual assignment on an assigned marketed medical device, progressively refined through tutorial discussion and feedback, followed by submission of a written report based on weeks 6-9.	20%	Week 09 Due date: 11 Oct 2026 at 23:59 Closing date: 11 Oct 2026	7 pages	AI allowed
Outcomes assessed:
Written work	Written Assignment Part 3 Each student will develop an individual assignment on an assigned marketed medical device, progressively refined through tutorial discussion and feedback, followed by submission of a written report based on weeks 10-13.	20%	Week 13 Due date: 08 Nov 2026 at 23:59 Closing date: 08 Nov 2026	7 pages	AI allowed
Outcomes assessed:

Assessment summary

This unit has four assessment events:

1.Written assignment part 1 based on activities completed during tutorials in Weeks 2–5 (20%)

2.Written assignment part 2 based on activities completed during tutorials in Weeks 6-9 (20%)

3. Written assignment part 3 based on activities completed during tutorials in Weeks 9–13 (20%)

4. Final exam covering content from week 1 to week 13 (40%)

Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2021 (Schedule 1).

As a general guide, a high distinction indicates work of an exceptional standard, a distinction a very high standard, a credit a good standard, and a pass an acceptable standard.

Result name	Mark range	Description
High distinction	85 - 100	To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at an exceptional standard as defined by grade descriptors or exemplars established by the faculty.
Distinction	75 - 84	To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at a very high standard as defined by grade descriptors or exemplars established by the faculty.
Credit	65 - 74	To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at a good standard as defined by grade descriptors or exemplars established by the faculty.
Pass	50 - 64	To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at an acceptable standard as defined by grade descriptors or exemplars established by the faculty.
Fail	0 - 49	To be awarded to students who, in their performance in assessment tasks, fail to demonstrate the learning outcomes for the unit at an acceptable standard established by the faculty. This grade, with corresponding mark, should also be used in cases where a student fails to achieve a mandated standard in a compulsory assessment, thereby failing to demonstrate the learning outcomes to a satisfactory standard. In such cases the student will receive the mark awarded by the faculty up to a maximum of 49.

For more information see sydney.edu.au/students/guide-to-grades.

For more information see guide to grades.

Use of generative artificial intelligence (AI)

You can use generative AI tools for open assessments. Restrictions on AI use apply to secure, supervised assessments used to confirm if students have met specific learning outcomes.

Refer to the assessment table above to see if AI is allowed, for assessments in this unit and check Canvas for full instructions on assessment tasks and AI use.

If you use AI, you must always acknowledge it. Misusing AI may lead to a breach of the Academic Integrity Policy.

Visit the Current Students website for more information on AI in assessments, including details on how to acknowledge its use.

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

Deduction of 5% of the maximum mark for each calendar day after the due date.
After ten calendar days late, a mark of zero will be awarded.

This unit has an exception to the standard University policy or supplementary information has been provided by the unit coordinator. This information is displayed below:

The Assessment Procedures 2024 provide that any written work submitted after 11:59pm on the due date will be penalised by 5% of the maximum awardable mark for each calendar day after the due date. If the assessment is submitted more than ten calendar days late, a mark of zero will be awarded. For each quiz, a Special Consideration is required in order to facilitate a re-take of the quiz or other assessment event to manage the circumstances.

Academic integrity

The University expects students to act ethically and honestly and will treat all allegations of academic integrity breaches seriously.

Our website provides information on academic integrity and the resources available to all students. This includes advice on how to avoid common breaches of academic integrity. Ensure that you have completed the Academic Honesty Education Module (AHEM) which is mandatory for all commencing coursework students

Penalties for serious breaches can significantly impact your studies and your career after graduation. It is important that you speak with your unit coordinator if you need help with completing assessments.

Visit the Current Students website for more information on AI in assessments, including details on how to acknowledge its use.

Learning support

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

Support for students

The Support for Students Policy reflects the University’s commitment to supporting students in their academic journey and making the University safe for students. It is important that you read and understand this policy so that you are familiar with the range of support services available to you and understand how to engage with them.

The University uses email as its primary source of communication with students who need support under the Support for Students Policy. Make sure you check your University email regularly and respond to any communications received from the University.

Learning resources and detailed information about weekly assessment and learning activities can be accessed via Canvas. It is essential that you visit your unit of study Canvas site to ensure you are up to date with all of your tasks.

If you are having difficulties completing your studies, or are feeling unsure about your progress, we are here to help. You can access the support services offered by the University at any time:

Support and Services (including health and wellbeing services, financial support and learning support)
Course planning and administration
Meet with an Academic Adviser

Weekly schedule

WK	Topic	Learning activity
Week 01	How & why medical devices are regulated	Lecture (1.5 hr)
Week 02	Regulatory instruments relevant to medical devices	Lecture (1.5 hr)
Week 02	Research the subject device, and prepare • Risks involved in use of the device, and how regulation mitigates those risks •Jurisdictions in which the device is already registered •The pre-market regulatory pathway used in each jurisdiction where registered •Post-market events (AEs, recalls, field actions, safety notices, etc) related to the device reported in any jurisdiction.	Tutorial (1.5 hr)
Week 03	Quality and regulatory requirements for product development	Lecture (1.5 hr)
Week 03	For the assigned target market for the subject device, prepare: • Applied Medical Device Regulations List • Applied Standards List	Tutorial (1.5 hr)
Week 04	Medical device testing and test laboratories	Lecture (1.5 hr)
Week 04	Prepare a high-level Design Description for the device and classify your medical device according to the applied regulations, provide a justification, and prepare a high-level project plan for the required regulatory & quality activities.	Tutorial (1.5 hr)
Week 05	Interpretation of regulations	Lecture (1.5 hr)
Week 05	Prepare detailed verification & validation (V&V) Plan and manufacturing block diagram	Tutorial (1.5 hr)
Week 06	Failures and exceptions in design verification and validation	Lecture (1.5 hr)
Week 06	Identify a particularly conservative or liberal interpretation taken in the regulatory classification & plan & suggest an alternative interpretation	Tutorial (1.5 hr)
Week 07	Failures and exceptions in medical-device manufacture	Lecture (1.5 hr)
Week 07	Choose 3 different activities in the V&V Plan, predict one specific example of a failure or exception that might be encountered	Tutorial (1.5 hr)
Week 08	Changes to medical devices and related regulations	Lecture (1.5 hr)
Week 08	Choose 3 different steps in the manufacturing block diagram, predict one specific example of a failure or exception that might be encountered	Tutorial (1.5 hr)
Week 09	Assessing and dispositioning design failures/exceptions device design	Lecture (1.5 hr)
Week 09	Propose one specific significant change (to the Device Description) and ientify one recent change to regulatory requirements applicable to the device.	Tutorial (1.5 hr)
Week 10	Assessing and dispositioning failures/exceptions in device manufacture	Lecture (1.5 hr)
Week 10	Consider the peer’s alternative interpretation & describe the factors that would come into consideration when determining which interpretation to take	Tutorial (1.5 hr)
Week 11	Labelling of medical devices	Lecture (1.5 hr)
Week 11	For each V&V failure/exception predicted by the peer: assess the risk and impact of the failure/exception, recommend appropriate disposition, and construct a supporting rationale	Tutorial (1.5 hr)
Week 12	Adverse events reporting and recall	Lecture (1.5 hr)
Week 12	For each manufacturing failure/exception predicted by the peer: assess the risk and impact of the failure/exception, recommend appropriate disposition, and construct a supporting rationale	Tutorial (1.5 hr)
Week 13	Review and consultation on assessments before final submission	Lecture (1.5 hr)
Week 13	Prepare plans of action to ensure regulatory compliance is maintained for the device change proposed by the peer and the regulatory requirements change identified by the peer	Tutorial (1.5 hr)

Attendance and class requirements

Students are expected to attend and actively engage in all timetabled activities of a unit of study. Students are required to be in attendance at the correct time and place of any formal or informal examinations and scheduled assessments. Non-attendance on any grounds insufficient to claim special consideration will result in the forfeiture of marks associated with the assessment.

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Learning outcomes

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University's graduate qualities and are assessed as part of the curriculum.

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

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1	Depth of disciplinary expertise Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.
GQ2	Critical thinking and problem solving Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.
GQ3	Oral and written communication Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.
GQ4	Information and digital literacy Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.
GQ5	Inventiveness Generating novel ideas and solutions.
GQ6	Cultural competence Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.
GQ7	Interdisciplinary effectiveness Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.
GQ8	Integrated professional, ethical, and personal identity An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.
GQ9	Influence Engaging others in a process, idea or vision.

Outcome map

Learning outcomes	Graduate qualities
Learning outcomes

Alignment with Competency standards

Outcomes	Competency standards
	National Standard of Competency for Architects - 2.2. Application of principles controlling planning, development and design for the project site.
	National Standard of Competency for Architects - 2.1. Identification, analysis and integration of information relevant to siting of project.
	National Standard of Competency for Architects - 2.2. Application of principles controlling planning, development and design for the project site.
	National Standard of Competency for Architects - 1.5. Knowledge of different procurement processes available and evaluation of the impact these have on the project.
	National Standard of Competency for Architects - 1.4. Identification of factors that may impact on client project requirements and objectives.
	National Standard of Competency for Architects - 1.3. Assessment of project budget and timeframe against project requirements and objectives.
	National Standard of Competency for Architects - 1.7. Preparation of project brief for approval by client and relevant stakeholders.
	National Standard of Competency for Architects - 1.2. Establishment, analysis and evaluation of client project requirements and objectives.
	National Standard of Competency for Architects - 1.4. Identification of factors that may impact on client project requirements and objectives.
	National Standard of Competency for Architects - 1.4. Identification of factors that may impact on client project requirements and objectives.

Responding to student feedback

This section outlines changes made to this unit following staff and student reviews.

The 2026 version of BMET5992 has been updated from previous versions, including revisions to the unit learning outcomes and their mapping, lecture topics, tutorial activities (for the first time), and assessment structure.

Additional information

Library access to standards

Disclaimer

Important: the University of Sydney regularly reviews units of study and reserves the right to change the units of study available annually. To stay up to date on available study options, including unit of study details and availability, refer to the relevant handbook.

To help you understand common terms that we use at the University, we offer an online glossary.

Current students

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Use of generative artificial intelligence (AI)

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Support for students

Weekly schedule

Weekly schedule

Attendance and class requirements

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Alignment with Competency standards

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Disclaimer

On this page

Useful links

BMET5992: Regulatory Affairs in the Medical Industry

Semester 2, 2026 [Normal day] - Camperdown/Darlington, Sydney

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Use of generative artificial intelligence (AI)

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Support for students

Weekly schedule

Weekly schedule

Attendance and class requirements

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Alignment with Competency standards

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Disclaimer

On this page

Useful links