&geometry(706x85) "Australian Dental Industry Association")
Posted in TGA
Refinements to the regulation of personalised medical devices
 "Refinements to the regulation of personalised medical devices")
As you are aware the ADIA has worked closely with the Therapeutic Goods Administration (TGA) over the past 18 months on the development of the personalised medical devices framework.
On Monday the TGA announced a number of options for refining the framework that were identified as a result of the public consultations held over the last few months.
The ADIA advocated for a number of options to be considered in the development of the framework which included:
- A review of Class 1 and Class IIa devices with a view to excluding very low risk products from Australian Register of Therapeutic Goods (ARTG) inclusion.
- Continuing to include raw materials and components that are used to make medical devices in the ARTG.
- Maintaining a level playing field for all manufacturers of medical devices.
- The ADIA suggested implementing a templated process to achieve a QMS system to reduce costs for the small laboratories and manufactures which was highlighted in a Risk Statement submitted by the ADIA in the initial consultation process.
In today's announcement the TGA have advised that:
- A limited number of low risk devices would be excluded from being considered to be medical devices.
- Raw materials and components would stay on the ARTG.
- The person assembling the low risk device would not need to include the device in the ARTG.
- The person assembling the device, including if they are a healthcare practitioner, will still need to meet all other regulatory requirements for medical devices.
An overview of these legislative instruments and their impact can be found on the TGA website.
What is required now?
If you manufacture or supply a product that has been included in the excluded goods determination, you do not need to register for transition or include the device in the ARTG.
If you have already registered a product that has been included in the excluded goods determination you are not required to take any further action.
Please Note:
If companies reacted to the TGA email re removing items from the ARTG before June 30 by deleting those entries, the ADIA will work with the TGA on the process for reinstating those entries.
Please reach out to the ADIA with a summary of how many ARTG entries were cancelled, and also advise on any applications rejected on the basis of the TGA position on raw materials, that will now need to be resubmitted
| Posted in:TGAIndustry NewsCEO Updates |
TGA transition registration deadline of 25 August 2021
 "TGA transition registration deadline of 25 August 2021")
With the transition registration deadline of 25 August 2021 fast approaching, the TGA has produced a short video encouraging people to register their patient-matched medical devices for transition: https://youtu.be/MMGBU1-DoBg
| Posted in:TGAIndustry News |
TGA talks - 'Meeting Your Obligations' - FREE webinar
 "TGA talks - 'Meeting Your Obligations' - FREE webinar")
The Therapeutic Goods Administration will provide a FREE webinar on understanding TGA regulations next Tuesday August 24.
The webinar / workshop, 'Meeting Your Obligations', is part of the TGA's SME Assist service, which is dedicated to helping small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with therapeutic goods regulation understand their regulatory and legislative obligations.
The workshop will help navigate the regulatory maze so you can clearly understand your obligations at different stages of the regulatory process.
The SME Assist 'Meeting Your Obligations' workshop via live stream from the TGA office in Canberra, next Tuesday August 24 at 1:30pm.
Topics covered include:
- Basics of regulation - an overview of therapeutic goods regulation, the role of TGA and sponsor responsibilities when supplying therapeutic goods in Australia.
- Case studies - general principles of market authorisation, manufacturing, advertising and post-market monitoring as they relate to therapeutic goods.
- Q&A with TGA staff - opportunity to ask general questions.
When: Tuesday 24 August, 2021, 1:30pm to 4:30pm
Where: online via live stream.
| Posted in:TGAIndustry News |
Changes to the DBA fact sheet on the use and supply of teeth whitening products.
 "Changes to the DBA fact sheet on the use and supply of teeth whitening products.")
The Dental Board of Australia (the Board) has updated its fact sheet on using and supplying teeth whitening products for dental practitioners and this is now available on the Board's website.
The significant points of note are:
- Only registered dental practitioners can use and supply high concentration teeth whitening products.
- No current laws or regulations limit teeth whitening products to in-clinic use.
The fact sheet gives dental practitioners an overview of the laws and professional obligations that apply when they use teeth whitening products as part of their practice.
| Posted in:TGAIndustry News |
Canberra dental practice fined $266,400
 "Canberra dental practice fined $266,400")
Canberra dental practice fined $266,400 for alleged unlawful supply of dental implants and bone grafts
The Therapeutic Goods Administration (TGA) has issued 20 infringement notices to a Canberra-based dental practice totaling $266,400.
The alleged breaches of the Therapeutic Goods Act 1989 (the Act) include the importation and supply of dental implants (medical devices) and bone grafts (biologicals) that are not approved for use in Australia.
It is alleged that the company imported, supplied and implanted medical devices and biologicals in patients that were not entered into the Australian Register of Therapeutic Goods (ARTG).Under the Act, therapeutic goods must be entered into the ARTG before they can be lawfully supplied in Australia (unless a specific exemption, approval or authority applies).
Implanted therapeutic goods cannot be recalled, therefore the TGA has asked the dentist to notify all affected patients.The advice to patients contains information about the implanted products and the ongoing management of their implants.
Patients who have concerns should seek advice from a registered dental practitioner.If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
If you have concerns about health practitioners, notify the Australian Health Practitioner Regulation Agency (AHPRA).| Posted in:TGAIndustry News |
