While the consultation is open you can make a submission at our consultation hub.
We review the submissions. After that the submissions and our decision will be available on the same consultation page.
About this consultation
In response to feedback received during the introduction of the personalised medical devices framework, we are now reviewing regulatory pathways for medical devices manufactured at the point-of-care.
We are currently conducting four surveys, each targeted at major stakeholder groups involved in the manufacture of medical devices at the point-of-care.
The medical device manufacturing hubs at the point-of-care survey is for manufacturing hubs located in hospitals, clinics and other facilities where medical devices are manufactured (including academic and research-based facilities).
Information collected via these surveys will NOT be used to conduct compliance activities.
All recent TGA consultations can be found at the TGA consultation hub.