Have Your Say on the Proposed TGA Fees and Charges Increases – Deadline 20 March
Dear ODMA Members,
Please find below a communication from TGA that we wish to pass on to all ODMA Members. This is your chance to send specific input to the TGA regarding the proposed fees and charges increases and the impact it will have on your business specifically.
In December, I attended the Industry Bilateral Meeting on the optical industry’s behalf where the TGA presented a strategic and financial outlook. Here Association heads all expressed the current financial burdens on our industries and that no increases were supported or at most they would be in line with inflation.
Nevertheless sadly, it seems many TGA fees are due to go up substantially. This is due to the TGA’s cost recovery approach and their rising salary and corporate costs, also the impacts of Covid and ongoing changes for certain product compliance and medical device reforms, as well as we understand, a new building fit out.
We were also informed that the Government is supportive of the cost recovery method with industry fitting the bill for services so your voices to attempt to combat this are important. Please refer to the information provided by the TGA to estimate the impact for your specific business and express your concerns via this consultation paper process. The deadline is 20th March and the TGA communication sent to us is below.
I would also like to bring to your attention other TGA matters underway that may be important to your business, specifically -
The Clinical Evidence Guidelines of TGA, version 3.1, is found on the TGA website: Clinical evidence guidelines: Medical devices | Therapeutic Goods Administration (TGA) and now includes a new chapter on Ophthalmic Devices
Public consultations opened by the International Medical Device Regulators Forum (IMDRF) -
Non-In Vitro diagnostic Device Regulatory submission Table of Contents (nIVD ToC)
Link to consultation: Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC) | International Medical Device Regulators Forum (imdrf.org)
Start Date: 14 February 2023 Closing Date: 15 April 2023
IMDRF Working Group: Regulated Product Submission | International Medical Device Regulators Forum
In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)
Link to consultation: In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC) | International Medical Device Regulators Forum (imdrf.org)
Start Date: 14 February 2023 Closing Date: 15 April 2023
IMDRF Working Group: Regulated Product Submission | International Medical Device Regulators Forum
A general call by TGA for any businesses wanting to be involved to provide feedback on the quality of data held in the ARTG Register
Regards,
Amanda Trotman
Acting CEO
ODMA
TGA Communication to Industry
The TGA is conducting a public consultation to provide industry and othe interested stakeholders with an opportunity to formally comment on the TGA’s proposed fees and charges for the 2023-24 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed changes. The feedback will inform the final proposal to Government for consideration and a decision.
The consultation opened on Tuesday, 21 February 2023 and will close on Monday, 20 March 2023. Submissions in response to the consultation paper can be made during this four week period.
Kind regards,
Moya Smith
Assistant Director | Cost Recovery Management Section
Regulatory Engagement Branch | Regulatory Practice & Support Division
Health Products Regulation Group
Australian Government Department of Health
T: 61 2 6289 3391 | E: moya.smith@health.gov.au
Location: Level 2 South Gulgana Building Fairbairn
PO Box 100, Canberra ACT 2601, Australia
