In Reply to Parent Post by Highground
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.
My response below is based on my knowledge of the Australian medical devices regulatory system, and on my experience, including as an Australian sponsor. It's somewhat a shot in the dark though because I haven't seen what the TGA has written to your company, exactly
In my understanding if you qualify and register a system (a medical device) with the TGA, and the scope covers any components / spare parts / accessories that are initially supplied with / as part of the system, and some of those are later re-supplied to the system's end-user, they wouldn't require a separate registration (ARTG inclusion). However, if some of those items are supplied to other users independent of the system under which they were initially cleared, they might require their own inclusion, depending on what they actually are in the regulatory sense.
An accessory to a medical device is defined as an item that's intended by its legal manufacturer to enable
another* medical device to fulfill its own intended use
(as intended by the medical device's legal manufacturer). If a given medical device is able to fulfill its own intended use without the item in question, or the item's legal manufacturer didn't specifically intend their item to serve that specific medical device
, the item is not an accessory to that medical device. If there is no specific medical device which an item in question is an accessory to, it is not an accessory to a medical device at all.
The Australian system is very much the same as the EU one (under the MDD) and therefore there shouldn't be a major difference in the way the same situation is handled in both.
*) If the item is enabling a medical device that the item is officially a part of (eg a system), it's a component of that device and not an accessory to it.