@lizVR - Thank you very much for sharing your findings, much appreciated!
I do have to say they are a bit vague/inconsistent -
- They say that currently "no legislation enforces that policy" (I wonder whether that means that there is no explicit enforcement legislation in place, or no legislation to the effect mentioned at all), however, they used the wording "does need to be advised".
- "If the event lead to a corrective action of the device eg a Safety Alert or Recall action then yes Medsafe does need to be advised " - unclear to me whether that covers such actions taken anywhere in the world, or just in NZ.
I do have to say they are a bit vague/inconsistent -
- They say that currently "no legislation enforces that policy" (I wonder whether that means that there is no explicit enforcement legislation in place, or no legislation to the effect mentioned at all), however, they used the wording "does need to be advised".
- "If the event lead to a corrective action of the device eg a Safety Alert or Recall action then yes Medsafe does need to be advised " - unclear to me whether that covers such actions taken anywhere in the world, or just in NZ.