Revised: 12 March 2013
New Zealand has its own legal definition of a medical device. Suppliers of medical devices should be familiar with this to ensure the products they supply are appropriately regulated.
A summary of the key Acts and Regulations that may impact on the sale of medical devices. Other Acts and Regulations may also need to be complied with. It is the supplier's responsibility to ensure that its products comply with all applicable legislation.
For medical devices to be legally supplied in New Zealand they must be notified to the WAND database within 30 calendar days of a person or organisation becoming the sponsor of the device.
All importers of medical devices - be they subsidiaries, agents, "private label" suppliers, parallel importers, or direct importers - have obligations that must be complied with when supplying product in New Zealand.
Individuals and organisations manufacturing medical devices in New Zealand should ensure the devices are correctly notified to the WAND database. Manufacturing includes assembling of kits of medical devices, i.e. first aid kits, as well as device fabricators.
Contraceptive devices must comply with the requirements of the Contraception, Sterilisation and Abortion Act 1977 and with the appropriate approved Standards for contraceptives. Some products considered to be contraceptive devices in other countries are medicines in New Zealand.
Pregnancy test kits are medicines in New Zealand, while most other IVDs are regulated as medical devices. IVDs are currently exempt from mandatory notification to WAND, but must still comply with the requirements of the Medicines Act and its Regulations.
Safety related actions taken by manufacturers and suppliers to address issues affecting products in the market are called recalls and corrective actions.
Adverse events that cause injury and that are associated with medical devices may be indicative of a quality or safety issue that needs to be addressed in some form. By reporting these to Medsafe seemingly isolated incidents may be collated and responded to.
The Medicines Regulations establish minimum requirements for labelling of medical devices in New Zealand. Medical devices are expected to be labelled in accordance with international best practice.
All medical devices are expected to be supplied with appropriate instructions for use (IFU). Medsafe recognises the trend towards supply of instructions for use in electronic formats and has guidance regarding electronic IFU.
The Medicines Act and Regulations state what is, and is not, permitted when advertising medicines and medical devices. Devices that have, or are claimed to have, therapeutic properties must comply with the Medicines Act and Regulations.
Medsafe does not regulate or approve clinical trials for medical devices in New Zealand, but does request that it be informed of such trials. Clinical trials are conducted to determine the suitability of a product for a specific therapeutic purpose.
There are a number of organisations in New Zealand with an interest in medical devices. These include industry bodies, government agencies, and regulatory consultants.
Links to key medical device regulators from around the world.