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Adverse Event Reporting New Zealand

Ronen E

Problem Solver
Staff member
Super Moderator
#11
@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.
 
#12
@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 think, with this, the logic is inherent in the alert or recall, if such action occurs for devices sold in NZ, then yes they would need to be advised/notified. Hopefully the new legislation will be more clear and specific.

Thanks again for your guidance!
 
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