March 6 2013 Re: New Zealand Regulatory R
Post# of 403
March 6 2013
Re: New Zealand Regulatory Review for AsepticSure
Dear Mr. Brownson:
In response to your inquiry, we have contacted both Medsafe and the EPA in New Zealand to determine whether registration is required for the AsepticSure device. Specifically, MedSafe (Julie Lagan, Advisor (Product Safety), Compliance Management) has concluded that AsepticSure does not have a therapeutic effect and therefore is not considered a medical device.
With respect to the EPA (Antony Kitchener, Inbound Customer Service Operator,
Compliance Information), they have indicated the ozone generator is considered a manufactured item and therefore would not be regulated by the EPA. Further, the Hydrogen Peroxide is listed under the Organic Peroxides Group Standard and the permitted for use under the HSNO Approval Number for this Group Standard, which is HSR002629.
We hope this information is sufficient.
Respectfully,
Gordon Wehner
Regulatory Representative for Medizone International Inc.
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