When are Medical Device Accessories MD's?

[Highground]

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.

 

[sreenu927]

TGA registration (in Australia) is for each individual medical device/accessory and if it is a system, then each individual component of that system/pack.
The registration of your accessories has to be by GMDN Code. Identify the GMDN Code for those specific accessories, classify accordingly and provide necessary documentation to your Australian Sponsor.

Regards
Sreenu

 

[Highground]

TGA registration (in Australia) is for each individual medical device/accessory and if it is a system, then each individual component of that system/pack.
The registration of your accessories has to be by GMDN Code. Identify the GMDN Code for those specific accessories, classify accordingly and provide necessary documentation to your Australian Sponsor.

Regards
Sreenu

Thank you! This helps greatly!

 

[GCF21]

If your products have been registered with the TGA for 5 years my suggestion would be to speak to your Australian sponsor who should be able to advise on this.

 

[Ronen E]

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.

Hi,

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.

Cheers,
Ronen.

*) 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.

 

[Highground]

I have another question...several EU and Asian countries are asking for a DofC with all the accessories listed, even accessories to accessories. I'm not sure how to provide this information or if it should even be on the DofC since they are systems. The customer has a choice of different accessories so the system can be built to their needs. Should I just make this a statement of some sort with all possible accessories?

 

[locutus]

Just a comment that I have seen multiple regulatory agencies wanting all of accessories of devices listed, as mentioned above especially if they are sold separately or for different purposes. This is a way that the regulatory agencies are keeping track of all products coming into their country. It also might benefit in order to not have your shipments held at border control.

 

[Ronen E]

I have another question...several EU and Asian countries are asking for a DofC with all the accessories listed, even accessories to accessories. I'm not sure how to provide this information or if it should even be on the DofC since they are systems. The customer has a choice of different accessories so the system can be built to their needs. Should I just make this a statement of some sort with all possible accessories?

This is too much of a general question to answer. To provide some meaningful and responsible answer I whould have needed access to the relevant specific documentation and details. Sorry.

 

[Highground]

Okay. Let me put it this way.

It's a monitor that is useless without the sensors and vice versa The sensors are 6 different sizes according to the physiology of the patient. So a hospital might buy only 2 sizes, which does happen. They can buy other sizes at a later date.
So it's a system when used together.
Component of the MD or an Accessory? I think I'm going to list all the sensors with their GTIN numbers.

I had to come back and edit this. I understand finally!! I just had to reread the responses from everyone.