Notify TGA before 1st May of intention to up-classify surgical mesh
Dear Sponsors
Do you have a surgical mesh medical device or a system or procedure pack containing a surgical mesh included in the Australian Register of Therapeutic Goods (ARTG)?
As you may be aware, the Therapeutic Goods (Medical Devices) Regulations 2002 has been amended to reclassify surgical mesh medical devices to Class III from 1 December 2018 with transitional provisions applicable to eligible ARTG entries.
IMPORTANT!
If you are a sponsors of an ARTG entry/entries eligible for transition, you must notify the TGA in writing about all surgical mesh devices included in the ARTG entry before the later of:
- 1 May 2019; or
- By the date that is 2 months after the ARTG entry commencement date (whichever is the later date).
If you do not comply with this requirement by the due date, your surgical mesh devices will no longer be eligible for the transitional provisions, and you will be required to stop importation and/or supply of your devices immediately.
Please note:
- If you decide to seek pre-market authorisation for your device at a later date, you will be required to submit an application for inclusion of a Class III medical device in the ARTG as per the usual application process and your surgical mesh device will not be eligible for the transitional provisions.
- If you are unsure whether your device comes within the category of surgical mesh medical device, and therefore whether you are required to notify the TGA, we advise that you provide information about your device and give reasons on why you consider your device is not subject to the reclassification requirements.
Information required
The notification must, at minimum, include the following information*:
ARTG entry number
| UPIs of all devices of the kind included in the entry | Types of variants for each device with the individual UPI | Whether the sponsor plans to submit a Class III ARTG inclusion application for the device (Yes/No/Undecided) | Comments (if required) |
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*It is preferable that this information is provided as an Excel spreadsheet.
You must send the notification to: DevicesReclass.Notify@health.gov.au.
For further information, please refer to the Reclassification of surgical mesh devices guidance material.
Advertising Hub
The advertising hub brings together news and information about the regulation of therapeutic goods advertising. It contains tools for both consumers and advertisers, including fact sheets, e-learning modules and forms for reporting illegal advertising and submitting enquiries. It also provides information about the changes to the framework for advertising therapeutic goods that are being implemented between 2018 and 2020.
https://www.tga.gov.au/advertising-hub
A copy of the TGA presentation on the Code with examples to illustrate the application of the key sections is available on the advertising hub.
TGA notice of intention to cancel products for non-payment of Annual Charges
Members
The Therapeutic Goods Administration (TGA) has advised us that it is assessing all Australian Register of Therapeutic Goods (ARTG) entries which have (i) overdue, and (ii) unpaid annual product charges. The advice has been given ahead of the TGA issuing decision letters to sponsors which will have the effect of cancelling any unpaid entries from the ARTG for the non-payment of annual charges.
Please note that if you have any unpaid and/or overdue annual charges, you are strongly encouraged to pay the charges as a matter of priority, or the goods relating to your ARTG entries will be cancelled from the ARTG effective on or after 12 March 2019.
Your prompt attention in this matter will help you to ensure you avoid your products being cancelled, which in turn will avoid you incurring further additional costs to restore or replace your products on the ARTG if you intend to commence or continue supplying your products in the market.
Important information for sponsors of medical devices (including Class I ‘other’ devices)
If you have one or more ARTG entries which is a medical device class 1 ‘other’ and the entry is cancelled for non-payment of annual charges, you will incur either an ARTG reinstatement application fee or a new inclusion application fee before your entry can be restored or replaced on the ARTG, thereby allowing you to continue supplying your products. It is important that all sponsors understand that application for inclusion fees are payable per each ARTG entry.
The 2018-19 annual charge for a medical device class I ‘other’ is (only) $90.00.
ARTG reinstatement and/or Application for Inclusion fees
If payment of your overdue annual charges is not received by the TGA before a decision is taken to cancel your entries; your only recourse after cancellation (if you wish to continue supply of your products) will be to either:
(i) apply to reinstate the product(s) back on the ARTG – the reinstatement application fee for a class I ‘other’ is $160 for the first ARTG entry and $50 for each after (or, at a minimum $70 greater than the current annual charge), additionally, you will still need to pay the outstanding annual charges on top of the reinstatement application fees before the reinstatement can be approved; or
(ii) if you decide to include the medical device class I ‘other’ as a new entry on the ARTG (under a new ARTG number), the inclusion of the new medical device class I ‘other’ will incur a $530.00 application fee to "include a class 1 device (other than an export only device)" in addition to any future annual charges you will incur.
Please be aware that supplying therapeutic goods that are not active on the ARTG or otherwise approved for supply may constitute an offence under the Therapeutic Goods Act 1989 (the TG Act), and may also attract civil penalties under the TG Act.
Contact
If you have any questions regarding this or any related matter, you can contact the TGA Billing Team directly on 02 6221 6900 or by email to accountsrec@health.gov.au.
Brexit Statement
https://www.tga.gov.au/brexit-implications-therapeutic-goods-australia
Communication conduct with TGA
All TGA staff abide by the Australian Public Service Values and Code of Conduct in all aspects of our business. This customer service charter sets out our commitment to the standards of service you can expect in your dealings with us, as well as what we can assist you with.
TGA staff will:
- be helpful and treat you with courtesy
- acknowledge your letters and emails within 5 working days and ensure that our responses to you are timely, relevant and easy to understand
- where a full response cannot be provided within 5 working days, we will advise you when a response can be expected and keep you informed on progress if the issue is complex
- respond to voice mail messages within two working days
- identify ourselves to you on the telephone and in our letters and emails we will include contact details
- provide you with background and reasons for adverse decisions
- provide information and guidelines in plain language
- respect your right to privacy and confidentiality
In return, TGA expects that when engaging with our staff, representatives of medical device sponsors will:
- treat TGA staff with respect and conduct themselves in a professional courteous manner
- provide complete, clear responses to TGA requests within legislative timelines
- not engage in an aggressive, intimidating or demeaning manner
Should you or a member of your organisation experience behavior that is not consistent with the TGA customer service standards, or you are experiencing difficulties engaging constructively with a member of staff, please contact TGA via devices@tga.gov.au. Please include as much relevant detail as you can regarding the matter.
More information on TGA customer service standards and privacy can be found on the TGA website https://www.tga.gov.au/tga-customer-service-standards.
