IVD Australia Submission- Pre-market Assessment Proposal
IVD Australia has responded to the invitation from TGA to submit comments on the "Changes to the pre-market assessment requirements of medical devices ”
You can download the submission here.
IVD Australia Submission- ANTZPA
IVD Australia has respoded to the invitation to submit comments on the "Description of a possible joint regulatory scheme for therapeutic products under Australian and New Zealand Therapeutic Products Agency (ANZTPA)”
You can download the submission here.
IVD Australia Submission- Blood Glucose Test Strips
In January the Government through the PBS called for comments on the draft report of Stage 1 of the Review into products used for the management of Diabetes focussing on Blood Gluclose Test Strips (BGTS). CEO, Peter Harman, with the assistance of the IVD Australia Diabetes Working Group submitted comments which can be found here.
The Diabetes Working Group will make further comment when the final draft of the report is released.
Technical & Regulatory Workshop
MELBOURNE- 20 JUNE 2013
IVD Australia will again be presenting our comprehensive introductory workshop on all aspects of TGA regulation of IVDs.
This workshop will be presented in Melbourne on June 20th, with further dates should there be a sufficient demand.
This interactive workshop will give participants a comprehensive understanding of the processes and functions of the recently introduced regulations. Expert presenters will lead participants through the strategic considerations and practical steps of applying for inclusions, illustrated with real world, complex examples.
Topics
- Introduction to the regulations
- Classification and grouping of IVDs
- Essential Principles
- Manufacturers Evidence
- Technical File Review
- Submitting an Application for Inclusion
Presenter: Dr Peter Harman - CEO IVD Australia
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When: |
Thursday 20 June 2013 l 9:30am- 4:00pm |
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Where: |
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934 Doncaster Rd Doncaster VIC |
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Cost: |
Members: $495 |
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Non Members $880 |
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Questions? |
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Registration |
Click here to register |
- Tanzanian changes to diagnostic medical devices
31 January 2013 - Victoria offers rapid HIV test
13 January 2013 - Cuts to pathology fears
28 December 2012 - Greenlight for 30min HIV test
18 December 2012 - Blueprint for TGA reform
December 2012
- Consultation with TGA on the IVD Framework
- Networking opportunities for you and your staff
- A voice for Australian manufacturers and independent distributors
- A means of influencing the development of the IVD industry in Australia
Read our Value Proposition
