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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
Consultations on adoption of European Union guidelines in Australia

The EU guidelines below have been recommended for adoption or non-adoption by the TGA. These guidelines are open for comment on whether or not they should be adopted in Australia.

Submission of comments

Your comments on the proposed adoption or non-adoption of these EU guidelines, particularly your advice on whether you support the proposed action, would be appreciated.

Comments may be sent by email or mail and should include your full contact details.

The email address for comments is: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

The postal address for comments is:

EU/ICH Guidelines Coordinator
Office of Medicines Authorisation
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

For more information please follow the link https://www.tga.gov.au/newsroom/consult-pm-euguidelines.htm