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New Zealand's Regulatory Environment

Proposed New Zealand legislation impacting medical devices

The Australian and New Zealand Governments took the decision in November 2014 to cease work to establish the Australia New Zealand Therapeutic Products Authority (ANZTPA) following an assessment of the needs and perspectives of both countries.

The New Zealand Government is now preparing legislation to reform the domestic regulatory arrangements for therapeutic products with the intention to replace the Medicines Act 1981. The draft Rules are expected to be exposed for consultation early 2017.

The Ministry of Health released papers setting out the key decisions to date on the therapeutic products regime on April 28th 2016

Cabinet papers November 2015
Therapeutic Products Regulatory Paper 1: Context and Overview
Therapeutic Products Regulatory Paper 2: Proposals for a Therapeutics Products Bill
The Regulatory Impact Statement for these two Cabinet Papers

Cabinet papers March 2016
Therapeutic Products Regulation Paper 3: further policy approvals
The Regulatory Impact Statement for this Cabinet Paper

These documents can be viewed at MedSafe - Health and Disability

Current New Zealand legislation impacting medical devices

The Medicines (Database of Medical Devices) Regulations 2003 came into force on 1 January 2004. These Regulations require the Director General of Health to maintain a database ("WAND") of all medical devices supplied in New Zealand.

A sponsor (i.e. any New Zealand-based person or organisation that is manufacturing or importing medical devices for supply in New Zealand, or exporting medical devices) is required to enter details into a medical device database within 30 days of commencing supply or export of a new medical device.

WAND is a notification database only, and is reliant only on information provided by sponsors about their products. Inclusion of a notification on WAND does NOT indicate approval or any other endorsement of the device by Medsafe.

For further information and obtain instructions for WAND notification click here


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