3.3 Australian Legislative Framework: Company roles and responsibilities
Module 3.3 Australian Legislative Framework: Company roles and responsibilities forms part of the 3.0 Regulatory Requirements for Medical Technology.
A detailed review of how medical technology is regulated in Australia including the legislative framework for therapeutic products, regulatory model for medical devices, the operations of the TGA, how to make an application to supply a medical device and the relevant acts and regulations.
- Explores the Australian legislative framework for therapeutic products in broad terms, and specifically, the regulatory requirements for medical technology
- Understands the role and operation of the Therapeutic Goods Administration (TGA)
- Considers the many Acts and Regulations affecting the supply of medical technology in Australia
- Understands the specific legislative framework within which the TGA makes regulatory decisions.
Who should attend?
Regulatory professionals should attend the training. Module 3.2 Introduction to the Regulation of Medical Technology in Australia or equivalent industry experience are the recommended pre-requisites for this Level 2 module.
How much does it cost?
The cost of this full day module including GST is $950 for members and $1575 for non-members. Once payment is accepted, applicants will be registered. Standard credit card fees apply.
How do I register?
This module has not been scheduled. To register your interest, please click on the Register Your Interest button below.Once sheduled, payment must be made by Credit Card (Visa, MasterCard or American Express) at the time of booking. Credit card payments are processed via our secure registration provider, Securepay.
Changes & cancellations
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If a cancellation is made less than five days prior to an event, without prior notice or substitution, there will be no refund. Should MTAA cancel an event, a full refund will be made.
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