TGA changes to legislation governing custom-made medical devices

The Therapeutic Goods Administration (TGA) has recently announced changes to legislation taking effect on 25 February 2021, that will affect any dentist who is manufacturing, importing or supplying custom-made medical devices.

The main impact of these changes is that devices currently being supplied as custom-made medical devices will now need to be included in the Australian Register of Therapeutic Goods (ARTG).

The ADA is recommending that dentists familiarise themselves with the TGA Guidelines (see below) and determine if they meet the criteria for manufacturing and importing patient-matched devices under the new definitions.

To qualify for transitional arrangements, dentists will need to:

1. Notify the TGA that they are a sponsor of what are currently called custom-made medical devices.

2. Apply for the transition period before 25 August 2021 and;

3. Submit an application for inclusion in the ARTG for each kind of device by 1 November 2024.

The ADA is doing everything it can to minimise the impact of these changes.

It is currently working to understand the specifics and implications of the legislative change and sourcing answers from the TGA so that greater clarity can be brought to the changes and what they will mean for dentists.

As an important first step, a special webinar with representatives from the TGA has been arranged for ADA members, to be held on Tuesday 9th March at 8 pm AEDT, which will provide an opportunity for them to ask questions and raise their concerns.

Questions can be submitted ahead of time by emailing [email protected] with “TGA question” in the subject line.

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