New Zealand's Regulatory Environment
Medsafe Incident Reporting
Please click here to view the process for reporting medical device incidents
Proposed New Zealand Therapeutic Products Legislation impacting medical devices
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 Therapeutic Products Legislation is now exposed for a consultation period that ends on April 18th 2019.
Prior to the release of the Therapeutic Products Legislation for consultation Cabinet released a number of papers.
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 initial documents can be viewed at MedSafe - Health and Disability
The draft Therapeutic Products Bill and the Consultation documents can be viewed on the Medsafe Website.
MTANZ member companies are encouraged to participate in this consultation either in concert with MTANZ, individually or both.
On the 19th and 20th March Medsafe held forums for Medical Devices and (Clinical Trials) Research for the industry. The Medsafe presentations from these respective forum may be downloaded as PDFs below.
Current New Zealand legislation impacting medical devices
http://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp
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