Definition of Manufacturer, Sponsor, Distributor in Australia Therapeutic Goods Act

[wangyang]

Dear all:

I have noticed in the Therapeutic Goods Act , the definition of the "manufacturer" is as follows:

(1) Manufacturers of medical devices
1. The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person’s name, whether or not it is the person, or another person acting on the person’s behalf, who carries out those operations.
2. If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person’s name, does one or more of the following using ready made products:
a. assembles the device;
b. packages the device;
c. processes the device;
d. fully refurbishes the device;
e. labels the device;
f. assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:
i. the labelling on the device;
ii. the instructions for using the device;
iii. any advertising material relating to the device;
iv. technical documentation describing the mechanism of the device.
3. However, a person is not the manufacturer of a medical device if:
a. the person assembles or adapts the device for an individual patient; and
b. the device has already been supplied by another person; and
c. the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:
i. the labelling on the device;
ii. the instructions for using the device;
iii. any advertising material relating to the device.
iv. technical documentation describing the mechanism of action of the device
A person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations for the purposes of this subsection.



From the above definition, i am not sure in the OEM mode, does the contracted manufactuer will be considered to be the manufactuer, or the OEM will be the manufactuer?

In another mode, if the manufactuer sell the medical device to an U.S distributor, then sold to the Australia market, what kind of responsibility should the U.S distributor serve as?

(2): Difference between the sponsor and the distributor.

In TGA 's regulation, i have found the definition and the responsibility of the " sponsor", however, i am not sure if there is any difference between the sponsor and the distributor. If there is more than one distributor, it seems that they all have to include the medical device into ATRG. The evidance can be found from ARGMD:


"If someone intends to supply a device that is identical to a device that is already in the ARTG, even if both devices are made by the same manufacturer, an application to include the device in the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia; it is also a record of all the sponsors who are legally responsible for the medical devices on the market. "

Does it mean that every distributor should include the same medical device into the ATRG and serve as a SPONSOR in fact?


Any response will be appreciated.

 

[MIREGMGR]

Re: Question about Manufacturer, sponsor and distributor in Australia

in the OEM mode, does the contracted manufactuer will be considered to be the manufactuer, or the OEM will be the manufactuer?

In the general case, and using EU definitions of terms, the OEM is the regulatorily responsible Manufacturer, even if another company contract-makes the device.

In another mode, if the manufactuer sell the medical device to an U.S distributor, then sold to the Australia market, what kind of responsibility should the U.S distributor serve as?

None, as long as the manufacturer is the regulatorily responsible Manufacturer and (assuming that the Manufacturer is located outside Australia) there is an Australian Sponsor.

(2): Difference between the sponsor and the distributor.

In TGA 's regulation, i have found the definition and the responsibility of the " sponsor", however, i am not sure if there is any difference between the sponsor and the distributor. If there is more than one distributor, it seems that they all have to include the medical device into ATRG. The evidance can be found from ARGMD:

"If someone intends to supply a device that is identical to a device that is already in the ARTG, even if both devices are made by the same manufacturer, an application to include the device in the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia; it is also a record of all the sponsors who are legally responsible for the medical devices on the market. "

Does it mean that every distributor should include the same medical device into the ATRG and serve as a SPONSOR in fact?

You may have one distributor serve as Sponsor. This means that they're identified on all product labels, including those going to other distributors.


Or, you may have multiple distributors, all serving as Sponsors for the product versions they sell. This however multiplies your regulatory costs and complications.


Or, you may have an office or own operation in Australia, in which case the rules are different and you can represent your own products as an Australian company.


Or, you may hire a third party as your Sponsor, in order to keep all of your distributors on an even footing. Various companies offer this as a regulatory service.

 

[wangyang]

Re: Question about Manufacturer, sponsor and distributor in Australia

Thank you for your quick response, MIREGMGR.

In the general case, and using EU definitions of terms, the OEM is the regulatorily responsible Manufacturer, even if another company contract-makes the device.

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Does it mean that only the regulatorily responsible Manufacturer need to apply for TGA certification, and the contracted manufactuer doesn't have to.


None, as long as the manufacturer is the regulatorily responsible Manufacturer and (assuming that the Manufacturer is located outside Australia) there is an Australian Sponsor.

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Yes i know, thank you.



You may have one distributor serve as Sponsor. This means that they're identified on all product labels, including those going to other distributors.


Or, you may have multiple distributors, all serving as Sponsors for the product versions they sell. This however multiplies your regulatory costs and complications.


Or, you may have an office or own operation in Australia, in which case the rules are different and you can represent your own products as an Australian company.


Or, you may hire a third party as your Sponsor, in order to keep all of your distributors on an even footing. Various companies offer this as a regulatory service.

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Thank you.If i have many distributors and i choose to hire the third party as my sponsor, does all of the distributors, especially the domestic distributors, have to include my medical device into the ARTG?

 

[wangyang]

Re: Question about Manufacturer, sponsor and distributor in Australia

I have another question:

Many manufactuers may hold CE mark for a single medical device, why it is that? I mean, After my company apply for CE mark, my Client also apply for CE mark. I am totally confused.

 

[pkost]

Re: Question about Manufacturer, sponsor and distributor in Australia

I'm not entirely sure I understand your question here wangyang, however I suspect your client also CE marks the device so that they can put their name on it and not yours!

 

[MIREGMGR]

Re: Question about Manufacturer, sponsor and distributor in Australia

Note that if your customer is CE Marking a device that you make, and they do not have a relationship with you that gives them (1) control of the unchanged characteristics and performance of that device, and (2) access to, or the ability to regulatorily reference, your tech file on that device, their CE Marking basis may be questionable.

In general, that's not your problem, except that it's never good to have customers with questionable regulatory stances.

 

[MIREGMGR]

Re: Question about Manufacturer, sponsor and distributor in Australia

Does it mean that only the regulatorily responsible Manufacturer need to apply for TGA certification, and the contracted manufactuer doesn't have to.

Yes.

If i have many distributors and i choose to hire the third party as my sponsor, does all of the distributors, especially the domestic distributors, have to include my medical device into the ARTG?

No. Only your Sponsor lists the products.

 

[wangyang]

Re: Question about Manufacturer, sponsor and distributor in Australia

Yes.


No. Only your Sponsor lists the products.

"If someone intends to supply a device that is identical to a device that is already in the ARTG, even if both devices are made by the same manufacturer, an application to include the device in the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia; it is also a record of all the sponsors who are legally responsible for the medical devices on the market. "
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I agree with you, however, when i saw the above sentences, i am not sure if " someone" mean the "sponsor" or the "distributor"?

 

[wangyang]

Re: Question about Manufacturer, sponsor and distributor in Australia

I'm not entirely sure I understand your question here wangyang, however I suspect your client also CE marks the device so that they can put their name on it and not yours!

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Is such way acceptable according to EU directive/regulation?

 

[MIREGMGR]

Re: Question about Manufacturer, sponsor and distributor in Australia

"If someone intends to supply a device that is identical to a device that is already in the ARTG, even if both devices are made by the same manufacturer, an application to include the device in the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia; it is also a record of all the sponsors who are legally responsible for the medical devices on the market. "
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I agree with you, however, when i saw the above sentences, i am not sure if " someone" mean the "sponsor" or the "distributor"?

Only Sponsors list products.

If you have one distributor as your Sponsor, or you contract with a third party to be your Sponsor, or you open an office in Australia, then there would be only one listing.

If you followed the approach of having each distributor be a Sponsor, then they all would list.

If you contract with a third party in Australia to be your Sponsor, and separately sell product to someone else outside of Australia and unbeknownst to you they then sell that product to an independent distributor within Australia, that independent distributor would have to Sponsor the product sold to it, even though identical product was already on the Australian market.