Consultation: Proposed changes to the regulation of exempt medical devices and exempt other therapeutic goods
Consultation period:
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This consultation has closed. The consultation was open for feedback from 15 April 2024 to 9 June 2024 through an online survey hosted on the consultation hub - external site.
We sought feedback on proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods (OTGs). We invited feedback from stakeholders on three (3) proposals to improve the regulation of exempt medical devices and exempt OTGs:
Require notification of supply to the TGA
Publish information on the TGA website about supply
Provision of information and samples to the TGA.
Outcome of the consultation
We received thirty-eight (38) submissions from a range of stakeholders, including manufacturers, sponsors, healthcare providers from the fields of dentistry and allied health, hospitals, consumers, regulatory affairs consultants, and state and territory governments.
A summary of responses and individual responses in accordance with respondent’s consent has been published on the consultation hub - external site.
Next steps
We will review the feedback received and undertake further consultations with stakeholders as needed. We will inform stakeholders about any related policy or regulatory updates.