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Revised: 23 October 2019

Medical Devices

Regulatory Guidance

Policy Statements

Medsafe's policy related to particular types of medical device.

Importing Medical Devices into New Zealand

Obligations for medical device importers.

Contraceptive Devices

Information on standards for contraceptive devices.

In-Vitro Diagnostic (IVD) Devices

Definitions and exemptions.

Labelling of Medical Devices and Instructions for Use (IFU)

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

Advertising of Medical Devices

Definitions and legislation.

Conducting Medical Device Clinical Trials in New Zealand

Information for those conducting medical device clinical trials.

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