3.5 Submitting Applications to the TGA
Module 3.5 Submitting Applications to the TGA forms part of the 3.0 Regulatory Requirements for Medical Technology.
Provides practical learning in submitting applications to the TGA for medical devices, including IVDs. This module includes demonstrations of current relevant forms on the TGA’s eBusiness Services website.
- Learns how to navigate TGA’s eBusiness Services (eBS) web portal
- Learns how to complete TGA’s online forms related to medical devices
- Understands when/what attachments may be required and how they can be used to improve processing by TGA
- Understands the supporting documentation requirements for application audits and Conformity Assessments
- Understands how to submit certificate applications
- Learn about SAS and AP requirements
- Recognises the TGA’s procedures and expected time frames for processing applications.
Who should attend?
Medical technology industry employees working in regulatory affairs should attend the training. Module 3.3 Legislative Framework: Sponsor roles and responsibilities 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
Cancellations for all face-to-face training and events will be accepted up to five business days prior to the training and are subject to a cancellation fee of $50. Attendees from the same organisation may be swapped up to two working days prior to the training if MTAA is advised and agrees in writing. No refunds are issued for cancellations after this time. Please note, cancellations where payments were made online by credit card will be refunded less credit card fee(s).
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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