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

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

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

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.

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 :cool:

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.

Hi Grant,

Thanks for your help - much appreciated.

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


Dave :cool:

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

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

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.

I've found a useful page here: http://www.tga.gov.au/devices/devices.htm

Lots of useful medical device information...... (but not much cheese!)


Dave :cool:

Within the above mentioned site, a useful page is: http://www.tga.gov.au/international/index.htm

Which details various international co-operative agreements.


Dave :cool:

Hi Dave, Thanks for the links.
Could you reveiw my question in post #9 of this link and let me know what you think?
Thanks,
Bridget

Bridget,

The Govt. legislation here in Australia determines that the local distributor is responsible for obtaining the registration of the medical device. If they also put their name on your product, then the distributor is also determined to be the local "manufacturer".

Note: I gave a bit of incorrect information earlier - you actually cannot get an EU Notified Body to grant you approval to sell in Australia, though if you already have CE mark, it is very simple and you can do it over the web. If you don't have a CE Mark and you are a manufacturer of a new device in the US for example, and it is not a Class I device, then you have no alternative at this stage other than getting the Australian TGA to quality audit of your design &/or manufacturing facility (wherever it is in the world) and you must met all the Essential Principles of the Australian Regulations (like the Essential Requirements of the EU)

I know this is unreasonable and we are lobbying the Govt to change this. It affects us here also as an Australian design & manufacturing facility in that we must also get the TGA to audit us for our quality system as they don't accept ISO13485 certification granted by a 3rd party like the TUV.

It is a money making venture as far as we can see. I had an argument with the TGA last week at a conference about this very issue.

Cheers,

Grant.

Hello Bridget,

Regarding your post no. 9.

Certainly the local distributor can register a product on your behalf, and I’m sure they may been happy to do this, as their name will appear alongside your product in the register. Although I believe it is possible for you to register your own products – especially after reading the information at the “international” page detailed in post 12 above.

Grant, your comment on EU notified bodies not being able to give approval confused me a little. If you look on the international page (link above) and follow the link to the EC section, you will see a further link, titled: “Conformity assessment bodies (CABs) approved to undertake assessments to Australian requirements”, which gives a list of notified bodies and the type of products they can assess!

See what you think.


Dave :cool:

Dave/Bridget,

I’m sorry I confused you there. I was referring to having an EU Notified Body assess a US manufactured device to Australian Regulations. That is what I was correcting as Bridget was referring to a US manufactured medical device.

There is also confusion because the TGA is a bit like the FDA in the sense that they do not _necessarily_ recognise conformity assessments by private certifiers such as the TUV, SGS, BSI and the like to allow market approval in Australia (even they state that they do in their web site - they only do to an extent). There is “Confidence Building” happening – see below.

There are also differences in acceptability of Declarations of Conformity depending on the Class of device. If it is a Class I, then it is simple. If it is Class IIa or higher then there is an increasing probability that the TGA will want to audit the company themselves, though if you already have a CE Mark, then there is _usually_ no problem getting approval in Australia.

Having attended a TGA conference last week (put on by the TGA) , there is a “confidence building” programme going on with certain devices where currently they require a Conformity Assessment done by the TGA and as time passes, they are intending that a simple Declaration of Conformity and a CE Mark will be sufficient, though this probably will take some time (read years) for Class 3 devices.

In general overseas manufacturers who wish to supply new products to Australia
after 4 October will need to have evidence that the new Australian requirements
have been met before the product can be supplied in Australia. If you already have a CE Mark in the US, then the process is simple.

If you have an unapproved device in the US, the TGA will not accept a Conformity Assessment done by a European Notified Body such as the TUV for a device to be sold in Australia. Again though, this applies to Class IIa and higher.

If this seems a bit confusing, that is because it is confusing and you can get 2 different opinions from 2 different TGA employees. I, for example, personally know 3 people that now work for the TGA and I’ve raised these issues with them and I’ve received differing opinions as to whether the TGA would grant (virtually) automatic approval for a device manufactured by an overseas manufacturer or whether they would require that the overseas company be audited by the TGA itself.

Here is a statement from the TGA from last week’s conference here in Brisbane:

RECOGNITION OF ASSESSMENTS

• Full implementation of the European MRA is lagging. (note!!)

- confidence building program activities not yet performed.

• In the interim….

- The TGA will take into account the assessments performed by EU Notified Bodies to decide if the assessment is an acceptable part of the manufacturers evidence of conformity.
- The TGA intends to use MRAs as the preferred method for accepting overseas assessments.


So as you can see it is presently up to the TGA to assess each application even though it may have been effectively approved by a European CAB (Notified Body). This is different to the automatic granting of a CE Mark by a Notified Body here is Australia to allow market approval to the EU.

So again, the EU MRA does not apply to US Manufacturers – in other words, if you are a US manufacturer, you cannot get an EC CAB to assess to the Australian Regulations. That is what I was saying earlier when I corrected myself.

Australia does not have any MRA with the USA for medical devices at this stage, though if this FTA is approved and implemented it will be much easier. At this stage, a US manufacturer that does not have a CE Mark must show compliance with the Australian Regulations (for Class IIa and higher) with no short cut, and present the Technical File and Declaration of Conformance and submit to the TGA. This is very similar to an Australian manufacturer having to submit to the FDA. In that case, the FDA may undertake an audit of the Australian company at any time. Conversely, the Australian TGA state that they WILL require an quality system audit of the US manufacturer for to pre market approval, although I cannot see how this is practical possible.

I hope that hasn’t muddied the waters even more.

Cheers,

Grant.

Hi all:
Regarding the resigtration process I have not heard back from our distrubutor in Australia. I do not think they know that much about regulatory issues since they are basically a manufacturing facility. They do not CE mark their products but we do here in the US. So I guess I will have to start the ball rolling myself (again).

Thanks for the links to the website.
Thanks,
Bridget

Just thought you all might want to know that the small company that distributes our products in Australia is doing all of the work themselves! They have given me the name of the representative at the health department who is helping them. I emailed her to offer my assistance but it seems I am not needed.
There has got to be a catch somewhere!!!!
Bridget

That is great Bridget.

Whois the person assisting from the Health Dept (TGA). Is it Mike Flood, Keith Smith or Rod Ferreri? I am just curious.

Cheers,

Grant.

Thanks Grant for all the answers (& corrective action!)

I will add a couple more links that could be useful. Firstly for information about the content of AS 3551 which is not a mandatory TGA requirement, but may be specified by purchasers as an assurance that each and every device that is delivered to them is electrically safe. Relevant to 'active' or electrically powered medical devices only. I had a bit to do with writing this standard and is intended for the ongoing annual preventive maintenance of installed medical devices electrical safety. A guide for hospital biomedical engineers.
see <http://www.sai-global.com>

Regarding the TGA enforced regulations - up until Oct 2004 all devices previously 'listed' on the ARTG transferred to the MDD/AIMD/IVDD based 'NEW' legislation introduced in 2002. Have a look here to see what's listed <http://www.tga.gov.au/docs/html/artg.htm>

- Now every device must have a 'sponsor' or 'manufacturer' with a name and address in Australia. This is similar to the EU Representative requirement of the EU Directives. This is primarily so TGA can knock on someone's door when an incident occurs or a recall is required. Nothing revolutionary there, every country's legislation has Post Market Surveillance and Vigilance. Have a look at this site to see how the electronic registration of sponsors/manufacturers/ and agents can be registered <http://www.tga.gov.au/devices/dealfaq.htm>
Only one distributor in Australia needs to be registered, NOT every agent in every State.

- Every device group must be registered on the ARTG as an 'approved' device. Just terminology, nothing mysterious. It means as Grant has already stated above that the equivalent of an MDD Technical File must be created and the Essential Principles checklist completed.Probably the most significant difference is that there must be a Declaration of Conformity to the AUSTRALIAN REGULATIONS not the EU MDD. Once again all this can be done electronically via this web site <http://www.tgasime.health.gov.au/SIME/home.nsf>

- First requirement is to get the Australia sponsor registration number,
next

- File via SIME
a) the 'Manufacturers Evidence' of EC certificate, Q-System certificate (sometimes with 1st audit report), and DoC (all pdf format).


-then wait, and wait, and wait for this to be accepted, or heaven forbid, an audit may be requested.

- Next send in 'Application' along with A$0.00 for class I + A$50/year thereafter; A$670.00 for class IIa + I*sterile/measuring + A$670/year therafter; and heaps more for for Class III.

- then wait, and wait, and wait for this to be released (by email because that's quick!).

You see there is nothing to it really. That's why I have grey hair and have established CELEO to take care of this minor requirement for foreign manufacturers prior to placing medical devices on the Australian market.
Anyone who really does NOT want to do the above themselves, or fear their Australian distributor may change and thus the registration no longer be valid, could contact me for a helping hand.

Oh yes, to make it easier and to compound all the medical device registration requirements for Australia and New Zealand, a joint agency is in the throws of being established for implementation in 2005 (??).

Harmonization of regulations, now there's a novel idea. It should be global! :yes:

Hi everyone,

A couple of further clarifications following on from the detailed posts from Grant and Leo.

If you are outside of Australia and have a Class IIa or IIb device, then your local distributor can achieve TGA approval by submission of the CE certificate via TGA's electronic lodgement system DEAL. In practice, TGA accepts such certificates irrespective of country of origin.

There's potential confusion abut the manufacturer vs. Sponsor. They are different things - although one entity can be both for a given device. The sponsor is a bit like the European Representative - they are the legal entity responsible for the device in Australia and have to be an AUstralian company or person. The manufacturer is the person who does or arranges to be done, design, productions, release etc. and who maintains and holds the Tech File. and prepares the Declaration of COnformity.

So there is flexibility here, depending on who is declared to be a manufacturer. e.g. there could be an Australian company which arranges for manufacture in (say) CHina and declares themselves to be the manufacturer. In which case they (the Australian Co.) would hold the Technical File, control the Chinese Production activity under Vendor controls in the QMS and would be themselves be subject to full TGA conformity assessment. THis happens for some companies who outsource part but not all of their Aussie manufacture.

THe crucial detail is the labelling. The manufacturer must be identified, In the case of an AUstralian spoonsor and a declared overseas manufacturer this leads to labelling aliong the lines of "Manufactured by XYZ device co, CHina for ABC device Co Australia" with full contact addresses of both.

In this case, the Tec File is the responsibility of XYZ China, who in turn must have been CE certified by a Notified body recognised by TGA

Turning to NZ.

There is currently no premarket assessment requirement and very scant devices regulation in NZ - although there is now a notification database called WAND- which is a clone of the TGA's database. When the new joint Agency comes in, the WAND and ARTG databases will be merged and a joint regulatory assessment, approval and licensing scheme will emerege. But there's no back door way to Australia via NZ. Currently marketing in Australia requires approval by TGA granted to an Australian domiciled sponsor. Marketing in NZ requires separate notification on WAND by a NZ domiciled sponsor.


Arthur

In TGA's Medical Devices Guidance Document Number 5 they discuss class or category based on Schedule 3 Clause 1.8 or Schedule 3 6.6, etc.

My question is where is this Schedule 3? I searched the TGA website and didn't come up with anything. Can anyone help?

Thanks,

John

In TGA's Medical Devices Guidance Document Number 5 they discuss class or category based on Schedule 3 Clause 1.8 or Schedule 3 6.6, etc.

My question is where is this Schedule 3? I searched the TGA website and didn't come up with anything. Can anyone help?

Thanks,

JohnI believe it's schedule 2 and it's within the Australian Medical Devices Regulation. I've attached the regulation along with the Austalian Medical Devices Guidance Document 25, Classification of Medical Devices.

THe system here in Australia is indeed very much based on GHTF/EC regulations. If you are supplying IIa/IIb devices into Australia - they can be supplied based on your CE certification. The analogues are almost exact. The manufacture has to have conformity assessment certification (either direct by TGA or pre-existing CE.

Once the manufacturer certification is lodged with TGA (and reviewed and approved), then the Australian supplier ("sponsor") can apply for approval to supply devices within the scope of the certificate. This is done by entry on a register - the Australian Register of Therapeutic Goods (ARTG).

There has to be an Australian Sponsor - you can't supply direct - in a way analagous to the European Representative.

So in answeer to the thread - the manufacturer has to be "approved" by conformity assessment AND the devices have to be approved by placing on the register - that's a separate application process with approval based on the manufacturers conformity Assessment certification.

Oh and the manufacturers details have to appear on the label too.

The TGA website has all the devices stuff at http://www.tga.gov.au/devices/devices.htm

Arthur