Highground
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Hi Everyone,
I received this question from a person asking about the TGA...or telling me. Can anyone let me know how I need to register accessories if they apart of a whole system? We listed them as accessories and have been registered for 5 years with TGA, they also have their own UDI# Help?
This is the email.
The “system” is registered as a whole, including any components.
However, should a probe or other components, which are termed as Medical Devices (e.g. probe / sensor) are to be supplied separately at a later stage, the TGA requires us to register them separately as Medical Device on its own class (if they are classified as Medical Devices).
Therefore, I would like to have a clarification, whether on their own, the sensors such as venous xxx or arterial xxx or the flow probes for the system are considered Medical Devices or not?
If you are classifying them as “Non-Medical Devices” in EU, I would like you to confirm that.
======================
Any help would be appreciated.
I received this question from a person asking about the TGA...or telling me. Can anyone let me know how I need to register accessories if they apart of a whole system? We listed them as accessories and have been registered for 5 years with TGA, they also have their own UDI# Help?
This is the email.
The “system” is registered as a whole, including any components.
However, should a probe or other components, which are termed as Medical Devices (e.g. probe / sensor) are to be supplied separately at a later stage, the TGA requires us to register them separately as Medical Device on its own class (if they are classified as Medical Devices).
Therefore, I would like to have a clarification, whether on their own, the sensors such as venous xxx or arterial xxx or the flow probes for the system are considered Medical Devices or not?
If you are classifying them as “Non-Medical Devices” in EU, I would like you to confirm that.
======================
Any help would be appreciated.