Australia - The process to declare conformity for a class IIa medical device?

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pschnoor9

I am looking to declare conformity for a class IIa device in Australia. I have found the ComLaw regs for Therapeutic Goods (Medical Devices), and although it speaks to declaring conformity, it does not give enough specific information.

If we can demonstrate that our product conforms per the ComLaw standard, is that enough to issue a DoC? If so, is there a standard template?

If not, what is the process to follow to declare conformity? Does Australia accept EC certification? We are certified to ISO 13845, IEC 60601.1-1, ISO 9001:2003, and the MDD (93/42/EEC).

Any advice is appreciated.

patricia
USA
 
M

medic61

Re: Australia - anyone know the process to declare conformity?

I really can't answer all of your question but I know that Australia has their own rules and regulations in order to sell into the country and it is expensive. Our distributor retired in December and we started the process to sell directly to the doctors there but have put the project on hold as the starting costs were over 50,000 USD. Yes, having an EC certification helps the process but they require much, much more. At the moment we have the project on hold and may have to find another distributor in the country to share the costs with.
Good luck,
Bree
 
P

pschnoor9

Re: Australia - anyone know the process to declare conformity?

Thank you for your response, medic61. Your information is helpful, and leads me to ellaborate on our situation:

We do not want to distribute in AU directly - we sell our product (as a part of, or accessory to, a system) to other mfrs who then sell in AU. It is our OEMs that are asking about our product conformity to AU standards.

Will AU accept self declaration, or do they require 3rd party verification? Is there the equivalent of a notified body?

Thanks again for your response,

patricia
USA
 
M

Medevice

Re: Australia - anyone know the process to declare conformity?

Australia is regulated via the Therapeuic Goods Administration (TGA) through an Act of Parliament and associated Regulations. Devices are classed. The listing (ARTG inclusion) process requires self declaration for the lowest class I devices and self declaration plus conformity assessment by the TGA for higher class devices and class I devices that measure or are supplied sterile, if they are manufactured in Australia. IIa devices do require conformity assessment.

For devices manufactured overseas, the TGA will accept appropriate CE certification so long as a declaration of conformity is also made by the manufacturer that conforms to Australian requirements.

The Guidance section of the TGA web site has lots of information on requirements and processes. See http://www.tga.gov.au/devices/manuf.htm

Import of devices into Australia requires an Australian sponsor.

Hope that helps.
 
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M

Medevice

Re: Australia - anyone know the process to declare conformity?

We do not want to distribute in AU directly - we sell our product (as a part of, or accessory to, a system) to other mfrs who then sell in AU. It is our OEMs that are asking about our product conformity to AU standards.

Will AU accept self declaration, or do they require 3rd party verification? Is there the equivalent of a notified body?

The supply of the device into Australia is what is regulated. It is not reasonably possible to have a device included on the ARTG unless it is supplied into Australia. If the device you supply to OEMs is CE marked AS A MEDICAL DEVICE then the simplest path for the downstream manufacturer would be to have that device included as a part of a system. To do this your device would need to be included (registered) in Australia as a separate device leveraging its CE marking, and then have the system included under special rules for systems of devices where all component devices are already included separately. This is similar to the EC provision for systems of medical devices.

Except for the acceptance of appropriate CE markings, which is for overseas manufacture only, there is no Notified Body or Third Party assessment equivalent in Australia. All devices requiring assessment that are manufactured in Australia are assessed by the TGA directly. No exceptions.

Yep, it stinks, but there you are ... :confused:
 
P

pschnoor9

Re: Australia - anyone know the process to declare conformity?

Thank you to Medevice for your very helpful information and web link. I had found the ComLaw site, but had not been able to "dig" out the specifics.

Your assistance is much appreciated.
 
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