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Medsafe Adverse

Adverse Events

Medical Device Adverse Event Reporting
New ZealandMinistry of Health — MedsafeVigilance
What this code is

Adverse Events is the official Medsafe identifier for “Medical Device Adverse Event Reporting”. Adverse Events is the official identifier Medsafe uses for this instrument.

Instrument
Adverse
Full name
Adverse Events
Category
Vigilance
Source links
Authority source
English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
9 articles · 1 language version
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Dates
Published
Effective
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Medical Device Adverse Event Reporting

Medsafe guidance on reporting problems with medical devices: the changed incident-reporting process, reporting issues associated with medical devices, information for consumers, recommended reporting timelines (initial report as soon as possible and within 10 calendar days for death or serious injury, longer windows for minor injury and other events), why report a suspected adverse event, non-reportable events, the Medsafe process, and definitions. Page revised 19 March 2020 per its own stamp — the most recently revised page of this family; ingested from the exact official HTML with sec-1..sec-8 anchors.

Adverse Events is the official identifier Medsafe uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.