Regulatory Authority:
New Zealand Medicines and Medical Devices Safety Authority (Medsafe)
Classification
Medical Devices Class I (self-certified, sterile or measuring), Class IIa, Class IIb, III and AIMD.
In vitro medical-diagnostic reagents: no classification
Quality system
ISO 13485:2016
In New Zealand, Medsafe regulates Medical Devices, operating under the Medicines Act 1981 and associated regulations. No actual pre-market approval is required to market Medical Devices in the country. Still, devices must be notified to the WAND (Web-Assisted Notification of Device) database within 30 days of the appointment of a Sponsor.
The notification dossier must include administrative and technical information on the device, including device specifications and characteristics, device classification (based on risk), and safety and efficacy certifications from recognised bodies (e.g., an EU Notified Body, FDA, Health Canada). Before notification, the manufacturer must ensure that all documentation is ready, as Medsafe may request it at any time.
Inclusion in the WAND database does not amount to formal approval, but Medsafe reserves the right to remove devices that threaten public health from the market.
Applicant
Foreign manufacturers wishing to market their Medical Devices in the country must appoint a Sponsor, i.e. an Authorised Local Representative responsible for regulatory compliance of the device in New Zealand. The Sponsor is in charge of product notification and compliance management.
Timeframes and Costs
The notification must be submitted within 30 days of marketing and it is free of charge. The costs for the Sponsor vary according to the services offered.
Validity of the notification
There is no periodic renewal of the notification, but it must be updated in the event of significant changes, market withdrawals or discontinuation of distribution.
Documentation and Labelling Language
Documentation and labelling must be in English. The name and information of the Sponsor must be included in the labelling.
Other useful information
New Zealand recognises EC and FDA certification, facilitating the entry of devices that conform to these international standards. Medsafe carries out post-market surveillance to ensure the safety of devices, with clinical data reviews, field inspections and, if necessary, market withdrawals.
