Revised: 1 July 2014

Medical Devices

Regulatory Guidance

In-Vitro Diagnostic (IVD) Devices


Definitions and exemptions.

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Labelling of Medical Devices and Instructions for Use (IFU)


Labelling requirements and guidelines.
Instructions for use requirements and guidelines.

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Advertising of Medical Devices


Definitions and legislation.

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Conducting Medical Device Clinical Trials in New Zealand


Information for those conducting medical device clinical trials.

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