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Happy New Year, RAPs forum!
I am new to NZ registrations (and understand that Medsafe requires the listing of medical devices to be in WAND and in vitro devices are voluntarily listed in WAND-reliant on approval from EU NB, Health Canada, or US FDA).
I was wondering if anyone has experience with registering devices that can be considered in-between IVD and a medical device in other countries, like EU/AU.
Say, the device is glucose meter kit and includes lancets (and the kit could be sold together or individually). Lancets are considered medical devices in the EU/AU.
Would the kit and individual devices all be classified as IVDs? Or should the lancets be registered as medical devices and the rest of the kit registered as IVDs?
Any help would be appreciated! Thank you!