Yes, Australia's Therapeutic Goods Administration (TGA) may accept CE marking approval as a reference for the registration of medical devices and diagnostics under certain circumstances.
The TGA has a system in place called the "European Union Mutual Recognition Agreement (MRA)" which allows for the recognition of CE marking for certain classes of medical devices. This means that if a medical device has already been approved for the European market with a CE mark, it may be eligible for expedited registration in Australia.
However, it's important to note that CE marking 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 CE marking approval as part of the application process. The TGA will review the application and determine whether the CE marking 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 CE marking approval as a reference for medical device registration in Australia.
