Requirements for Exporting Medical Devices to Australia

[Bridget]

Hi,
Can anyone help me with the new regulatory system for medical devices in Australia? My company is in the US and I do not know where to start with this process.
I had also heard that New Zealand may also have regulations requiring a registration process, is this true?
Thanks,
Bridget

 

[Al Rosen]

Hi,
Can anyone help me with the new regulatory system for medical devices in Australia? My company is in the US and I do not know where to start with this process.
I had also heard that New Zealand may also have regulations requiring a registration process, is this true?
Thanks,
Bridget

Bridget:

We don't export to Australia and the term new is relative so I don't know if this is up to date but it may be helpful for a start.

http://www.ita.doc.gov/td/mdequip/Australiaregs.html

 

[Greg B]

Bridget,

Al's article is probably still current yet the links to the TGA are now corrupt. Here is the new link to Australia's Therapeutic Goods Administration. They deal with 'Regulating Australia's medicines, medical devices, blood, tissues and chemicals'.

They can be the mother of all Bureaucracies.

http://www.tga.gov.au/

Greg B

 

[Grant M.]

The regulation of medical devices in Australia is done by the TGA and the system that was introduced in October 2002 is now very, very similar to the European CE Marking system - in fact they copied it.

If you are familiar with the EU system, you are a long way to understanding the Australian system.

You basically must comply with the "Essential Principles" of our regulations, which are comparable with the “Essential Requirements” of the Medical Device Directive 93/42/EEC of the EU. You must also have a Quality System (again there is a choice of what sort, just like in the EU). You must submit a “Technical File” also as in the EU.

If you have a product that has a CE Mark, then you have virtually all of the information you need.

A Notified Body such as the TUV (who have branches in the US) should be able to grant you approval to sell in Australia on presentation of the Technical File to them, and provided you have an acceptable Quality System - such as ISO 13485 or 13488 certification.

Cheers,

Grant.

 

[Dave-h]

We have been selling into Australia & New Zealand for some time now - basically using our European CE approvals.

This morning I have received a note from an Australian distributor, saying that we will now also have to ensure compliance with NZS 3551:2004 (Technical management programmes for medical devices). I am just starting to look into it...


Dave

 

[Grant M.]

Would you like to buy some cheese?

You don't need to comply with this Standard to sell medical devices here. It's a local standard - Australia recognises the same Harmonised Standards as the EU. Here's a link specifically to the TGA Medical Devices site:

http://www.tga.gov.au/docs/html/meddevreg.htm

Cheers,

Grant.

 

[Dave-h]

Hi Grant,

Thanks for your help - much appreciated.

Now... what sort of cheese do you have for sale?.....


Dave

 

[Bridget]

Thanks for the links

I am glad I am not the only one who has yet to tackle this project. We only sell to one company in Australia and then they sell our name brand Class I and Class IIa medical devices(we gave them an exclusive). I have contacted them to see if they are aware of the regulations. Let's keep sharing info on this thread to keep us all updated on our issues.
Thanks,
Bridget

 

[Bridget]

Addtional Question

As I stated in my earlied post we do not sell to the end user in Australia, but sell to a distributor. Who is responsible to obtain the "licensing" in Australia, them or us? Our distributor sells his own Class IIa devices and then adds ours to round out his product offering. He leaves our label on the product he purchases from us.

Any ideas?
Bridget

 

[Grant M.]

Peruvian Goat's Cheese

For new products you need to comply with the new regs - as of Oct 2002 - you then get an "approved device". If you already had approval prior to then, you can continue to sell here under the old system with the "listed device" for 5 years (2007).

If you don't change the safety or efficacy of the device, then you can continue under the old system and it just requires the old usual safety testing. If oyu change the design (safety/efficacy) of an already listed device, then you then have to make a full submission using EU based data - the Technical File.

Cheers,

Grant.



Cheers,

Grant.