Posted in TGA

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

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.

Click here to Register and find out more information

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:

1. Only registered dental practitioners can use and supply high concentration teeth whitening products.
2. 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.

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.

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).

The advice to patients contains information about the implanted products and the ongoing management of their implants.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.

The Therapeutic Goods Administration (TGA) is requesting your comments on the following documents regarding Sterilisation and Substantial changes.

Background
The TGA guidance 'Checklist guidance to supporting data required for adding or changing sterilisation suppliers for TGA conformity assessment applications' provides additional detail on the documentation required for applications relating to sterilisation supplier changes. It is acknowledged that incomplete or inadequately prepared submissions can further lengthen TGA's review process.

We look forward to your thoughts. Please submit your response to policy@adia.org.au by close of business Monday, 11 May 2020. Feedback will then be compiled and submitted on Wednesday, 13 May 2020.