Yes, Australia's Therapeutic Goods Administration (TGA) may accept US FDA approval as a reference for the registration of medical devices and diagnostics under certain circumstances.
The TGA has established a regulatory framework that allows for the recognition of certain international approvals, including US FDA approvals, to streamline the registration process. This means that if a medical device has already been approved by the US FDA, it may be eligible for expedited registration in Australia.
However, it's important to note that US FDA approval is not automatically accepted by the TGA. The manufacturer will still need to submit an application to the TGA and provide evidence of the US FDA approval as part of the application process. The TGA will review the application and determine whether the US FDA approval is sufficient to meet Australian regulatory requirements.
It's recommended to consult with the TGA or a regulatory consultant for specific guidance on using US FDA approval as a reference for medical device registration in Australia.
