ISO 13485 Requirement in Australia/NZ for class 1?

#1
I have a simple product that is Class 1 here in the US that is registered with the FDA and on the market. We have distribution and sales covering most of the US. The product is also in Canada. We have a quality program that complies with the FDA, however we have not received ISO certification due to cost at this point. I have a distributor in Australia and NZ that would like to carry my product. By the Australian Regulatory Guideline website we are also a Class 1 Device. I would like to be able to move forward in those markets, but don't want to take the time and money at this point for 13485. If its relevant you could look at it on Anestand dot com.

I am unable to see on their website if the requirement exists for a device like mine that does not touch the patient and is not life sustaining.

Thanks in advance
 
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