Looking for Australian Sponsor for an impending TGA Submission

[Frodeno]

Hi Everyone,

We are looking for an Austalian sponsor for an impending TGA submission of a class II electrical medical device. I am aware of Emergo and a few smaller agents but would greatly appreciate any help with selection. My understanding is that the distributor must also be the sponsor - is this correct? Can anyone comment on the difference in cost between the larger companies and smaller agents ?

Thanks in advance,

Frodo

 

[Access2hc]

Re: Looking for Australian Sponsor

the distributor need not be the sponsor.
cost wise it is indeed a free market, hence the choice is based on the quality of service. as for the expertise you'd find out when they're in action with the TGA.

hope it helps

Cheers,
Ee Bin
Acces2hc

 

[Ronen E]

Re: Looking for Australian Sponsor

the distributor need not be the sponsor.

This is true only for a distributor that is not an importer.

 

[Frodeno]

Thanks to both of you for your replies.

So is it fair to say the following:

If we have an independant importer - they must be the sponsor?
If the sponsor is not an importer/distributor then the distributor also needs to be registered as a sponsor?

Maybe I`m getting confused....

 

[Ronen E]

Thanks to both of you for your replies.

So is it fair to say the following:

If we have an independant importer - they must be the sponsor?
If the sponsor is not an importer/distributor then the distributor also needs to be registered as a sponsor?

Maybe I`m getting confused....

It is quite simple. To import a medical device into Australia, or to arrange for its importation, you must be an Australian Sponsor of that device. A Sponsor which is not involved in the importation is quite useless for a device made off-shore. An Australian distributor who becomes a Sponsor will not help much unless they take responsibility for importation as well.

 

[fialor]

Hi Frodeno,
A sponsor does not need to be your importer or distributor. They are required to keep track of imports and this can be achieved by reporting to the Sponsor by the manufacturer.
I am in a positon where I have an australian sponsor for products into Australia.
They do not import nor are they the distributor, but the relationship works well.
PM me if you have any questions.
Fialor

 

[Ronen E]

Hi Frodeno,
A sponsor does not need to be your importer or distributor. They are required to keep track of imports and this can be achieved by reporting to the Sponsor by the manufacturer.
I am in a positon where I have an australian sponsor for products into Australia.
They do not import nor are they the distributor, but the relationship works well.
PM me if you have any questions.
Fialor

WOW, this comes a surprise to me as it seems to contradict language in both the 2002 Medical Devices regulations (as amended) and the TGA published guidance - the ARGMD (unfortunately, last revised in 2011). Regardless, I can't argue with apparent facts...

Is the TGA fully aware of this arrangement? Did they give their blessing to it?

"Keep track of imports" - how does it work (if I may ask)? Up until now the only slack from what I noted above was that the Sponsor was allowed to "be responsible for the importation of..." rather than actually import themselves, and I wasn't sure what it meant in practice. In all cases I was involved in, of off-shore made devices, the Sponsor was also the importer. Definitely "keep track of imports" sounds like a loose interpretation of "responsible for the importation". Very unlike the TGA I know!... I guess you learn something new every day.

 

[fialor]

The intepretation of "keep track of" is what is being applied here.
The sponsor gets a quarterly report of what is imported into the country from us, and this forms part of their records. The sponsorship agreement covers this as well.

As there is no detail of what "keep track of" entails, this interpretation is applied.
It has worked for a number of years for us, including for orthopaedic devices which are one of the closley monitored devices by TGA.

 

[Access2hc]

Yes Ronen E this is indicated in the regulations as fialor says.

Cheers,
Ee Bin
Access2hc