Review of draft guidance documents - Audit framework for medical devices
Overview
The Therapeutic Goods Administration (TGA) is seeking feedback on two new guidance documents developed as part of the new risk-based application audit framework:
1. Draft Guidance - Selection criteria for non-mandatory application audits.
This guidance document outlines and clarifies the selection criteria that influence when we select medical device applications for a non-mandatory application audit, including the rationale for the proposed criteria.
2. Draft Guidance - Medical device application audits: Case management process.
This guidance document outlines the case management model that will be used throughout the life cycle of an application audit. It details the process, timeframes, and the role of the TGA case manager.
Why your views matter
Your input is important to ensure the draft guidance outlines the background, key changes, and explains the new process for sponsors and manufacturers.
Your feedback will inform any changes to the guidance prior to publication on the TGA website.
If you prefer, you can make a submission directly to the Department via email at the following address:
tgamedicaldevices@health.gov.au
If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response. Please make any proposed amendments using tracked changes. Please also download and complete a copy of the cover sheet. Both are available via links at the bottom of this page.
Give us your views
Audiences
- Industry
- Sponsors
- Manufacturers
- Medical Devices & IVDs
Interests
- Hospitals
- Legislation
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