Course Description

The Australian Regulatory System for Medical Devices

Course Description:

This course examines how the Australian Regulatory System operates. It includes a detailed, comprehensive series that encompass both pre- and post-approval requirements for manufacturers, sponsors, importers, and exporters of medical devices.

This course imparts an essential, all-in-one introduction for medical device professionals who wish to gain an in-depth working knowledge of the Australian Regulatory System.

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Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Comprehend and define the working fundamentals of the Australian Regulatory System for Medical Devices, which includes:
    • Background of the Australian Medical Device industry
    • Structure of Australian legislation
    • Basics of EU medical device directives compared to those of Australia  
    • Regulatory authority
    • Pre-market approval process
    • Documentation and procedural requirements for conformity assessment
    • Conformity assessment routes
    • Classification
    • Listings on the Australian Register of Therapeutic Goods (ARTG)
    • Essential principles compared to essential requirements
    • Applications
    • Labeling
    • Post-market obligations
    • Recalls
    • Advertising

Who Should Enroll:

Regulatory Affairs Associate, Regulatory Affairs Manager, Quality Assurance Associate, Quality Assurance Manager, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Electrical Safety Engineer, Internal Auditor, Lead auditor, Pre-Clinical Study Manager, Export Manager, Clinical Affairs Director, and R&D Engineer are welcome to join this course

Prerequisite Knowledge/Requirements:

There is no specific prerequisite knowledge required for this course; however, it is recommended that learners be familiar with the GHTF/IMDRF documents.

Subject Matter Expert:
Paul Cohen

110 min

Release date:

Related resources:

Case studies:

Basic Account: € 325.00
Premium Account: € 244.00

Last update - 06/13/2016:

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