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BMET5992: Regulatory Affairs in the Medical Industry (2020 - Semester 2)

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Unit: BMET5992: Regulatory Affairs in the Medical Industry (6 CP)
Mode: Normal-Day
On Offer: Yes
Level: Postgraduate
Faculty/School: School of Biomedical Engineering
Unit Coordinator/s: Professor Li, Qing
Session options: Semester 2
Versions for this Unit:
Campus: Camperdown/Darlington
Pre-Requisites: None.
Prohibitions: AMME4992 OR AMME5992.
Brief Handbook Description: 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.
Assumed Knowledge: MECH3921 OR BMET3921 OR AMME5921 OR BMET5921 and 6cp of 1000-level Chemistry, and 6cp of Biology units
Additional Notes: Biomedical Engineering Elective Unit of Study.
Timetable: BMET5992 Timetable
Time Commitment:
# Activity Name Hours per Week Sessions per Week Weeks per Semester
1 Lecture 3.00 1 13
2 Independent Study 5.00
T&L Activities: Independent Study: Follow up research and assignment work.

Learning outcomes are the key abilities and knowledge that will be assessed in this unit. They are listed according to the course goal supported by each. See Assessment Tab for details how each outcome is assessed.

(7) Project and Team Skills (Level 3)
1. Ability to define a timeline and meet deadlines for completion of a complex project.
(8) Professional Effectiveness and Ethical Conduct (Level 3)
2. Understand and adhere to standard medical practices and ethical requirements as part of a product formulation.
(6) Communication and Inquiry/ Research (Level 3)
3. Ability to present findings of a design project in a concise fashion to peers.
(4) Design (Level 4)
4. Ability to formulate a biomedical product and adjust to suit specific requirements.
(2) Engineering/ IT Specialisation (Level 3)
5. A broad understanding of international regulatory requirements and the technical and engineering basis of these regulations as they relate to the practice of biomedical engineering in both industrial and clinical environments.
Assessment Methods:
# Name Group Weight Due Week Outcomes
1 Assignment* Yes 100.00 Week 12 1, 2, 3, 4, 5,
Assessment Description: Assignment submission requirements: Regulatory strategy report on nominated product to include design and production risks and validations, and premarket submission requirements for global product launch for a nominated medical device or diagnostic.

Assessment will be based on final project report and seminar presentation. There is no examination.

The assignment report is due in week 12.

* Students requesting special consideration are required to complete this assignment at a time that must be negotiated with the unit coordinator.
Grade Type Description
Standards Based Assessment Final grades in this unit are awarded at levels of HD for High Distinction, DI (previously D) for Distinction, CR for Credit, PS (previously P) for Pass and FA (previously F) for Fail as defined by University of Sydney Assessment Policy. Details of the Assessment Policy are available on the Policies website at . Standards for grades in individual assessment tasks and the summative method for obtaining a final mark in the unit will be set out in a marking guide supplied by the unit coordinator.
Policies & Procedures: See the policies page of the faculty website at for information regarding university policies and local provisions and procedures within the Faculty of Engineering and Information Technologies.
Note on Resources: Lecture notes will be supplied in class.

Note that the "Weeks" referred to in this Schedule are those of the official university semester calendar

Week Description
Week 1 Why regulate – some history and an introduction to global regulations. Introduction to course projects.
Week 2 The regulatory submission. Classification, Technical Files and Essential Principles/Requirements. FDA 510(k) and PMA processes.
Week 3 Guest Lecturer – TGA – realities of regulatory practice
Week 4 Risk management – ISO 14971 and related standards. Class case studies and exercises
Week 5 Design Controls. ISO 13485 and 21 CFR 820.30 requirements. Role of Industrial design.
Week 6 Technical standards. Electrical safety, biological testing, sterilization
Week 7 ISO 13485 Manufacturing controls. Documentation requirements. Process validation – guest lecturer from industry. Review of progress – student projects.
Week 8 Regulation of Emerging Technologies. Cellular therapies, Tissue engineered products, companion diagnostics.
Week 9 WEEE, RoHS, REACH and all that other stuff. Regulations on environmental compliance, genetic testing, hazardous materials and more.
Week 10 Postmarket. Reimbursement, market acceptance, continuing compliance: adverse events, registries, recalls. – Case studies.
Week 11 Review and summary
Week 12 Student project presentations.
Assessment Due: Assignment*
Week 13 Student project presentations.
Exam Period No exam. All assessment by assignment and seminar.

Course Relations

The following is a list of courses which have added this Unit to their structure.

Course Year(s) Offered
Biomedical Mid-Year 2021, 2018, 2019, 2020
Biomedical 2021, 2016, 2017, 2018, 2019, 2020
Biomedical/ Project Management 2019, 2020
Biomedical / Arts 2019, 2020
Biomedical / Commerce 2019, 2020
Biomedical /Science 2019, 2020
Biomedical/Science (Health) 2019, 2020
Biomedical / Law 2019, 2020
Biomedical/Science (Medical Science Stream) 2019, 2020
Master of Engineering 2019, 2020
Master of Professional Engineering (Accelerated) (Biomedical) 2019, 2020
Master of Professional Engineering (Biomedical) 2019, 2020

Course Goals

This unit contributes to the achievement of the following course goals:

Attribute Practiced Assessed
(7) Project and Team Skills (Level 3) No 20%
(8) Professional Effectiveness and Ethical Conduct (Level 3) No 20%
(6) Communication and Inquiry/ Research (Level 3) No 20%
(5) Interdisciplinary, Inclusiveness, Influence (Level 4) No 0%
(3) Problem Solving and Inventiveness (Level 4) No 0%
(4) Design (Level 4) No 20%
(2) Engineering/ IT Specialisation (Level 3) No 20%

These goals are selected from Engineering & IT Graduate Outcomes Table 2018 which defines overall goals for courses where this unit is primarily offered. See Engineering & IT Graduate Outcomes Table 2018 for details of the attributes and levels to be developed in the course as a whole. Percentage figures alongside each course goal provide a rough indication of their relative weighting in assessment for this unit. Note that not all goals are necessarily part of assessment. Some may be more about practice activity. See Learning outcomes for details of what is assessed in relation to each goal and Assessment for details of how the outcome is assessed. See Attributes for details of practice provided for each goal.