Information for Medical Device Suppliers
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and is the regulator for medicines and medical devices supplied in New Zealand. Medsafe is business unit of the New Zealand Ministry of Health.
This page provides links to a broad range of information relating to the supply of medical devices within New Zealand.
Definitions
Legislation
The WAND Database
Importing Medical Devices
Manufacturers of Medical Devices
Contraceptive Devices
In-Vitro Diagnostic (IVD) Devices
Recalls and Corrective Actions
Adverse Event Reporting
Labelling Requirements
Instructions for Use
Advertising of Medical Devices
Clinical Trials
NZ Medical Device Organisations
Overseas Medical Device Regulators
Definitions
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. Note that the supply of products as medical devices that are medicines may breach the Medicines Act 1981.
Explanation of the New Zealand definition of a medical device
Legislation
The Medicines Act 1981 and its Regulations describe the regulatory scheme for the supply of medical devices in New Zealand. However, some medical devices may be affected by other legislation which must also be complied with before the devices may be legally supplied. Following is 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.
Information about some of the Acts and Regulations that may impact on medical devices
The WAND Database
For medical devices to be legally supplied in New Zealand they must be notified to the WAND database. Notification of medical device information to the WAND database is free and there are no on-going fees. Devices must be notified to the WAND database within 30 calendar days of a person or organisation becoming the sponsor of the device. A sponsor is a person or organisation that imports, exports a device or that manufactures or arranges the manufacture of a device in New Zealand. The notification of medical devices to the WAND database does not constitute an approval process. However it is mandatory so the Director-General of Health has details about the medical devices supplied in this country. The information is confidential to the Ministry of Health.
Importing Medical Devices
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.
Summary of importer obligations
Definition of a Medical Device Manufacturer
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.
Information for local, NZ, manufacturers of medical devices
Contraceptive Products
Contraceptive devices must comply with the requirements of the Contraception, Sterilisation and Abortion Act 1977. Products must comply with the appropriate approved Standards for contraceptives. Some products considered to be contraceptive devices in other countries are medicines in New Zealand.
Information about contraceptive products
In-Vitro Diagnostic (IVD) Devices
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 they must still comply with the requirements of the Medicines Act and its Regulations. IVDs may be voluntarily notified to the WAND database.
Recalls and Corrective Actions
Safety related actions taken by manufacturers and suppliers to address issues affected products in the market are called recalls and corrective actions. These should be conducted in consultation with Medsafe according to the MoH Uniform Recall Procedure for Medicines and Medical Devices.
Information about conducting a recall or corrective action
Adverse Event Reporting
Adverse events that cause injury and that are associated with medical devices should be reported to Medsafe. Such events 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.
Information about medical device adverse event reporting
Labelling Requirements
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.
Information about medical device labelling
Instructions for Use
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.
Guidance on instructions for use provided with medical devices
Advertising of Medical Devices
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.
Guidance for advertising of therapeutic products
Clinical Trials
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. This can be the testing of a pre-production product or the use of a product for a new indication or application. Medical device clinical trials require ethics committee approval and are expected to be conducted in accordance with international best practice guidelines.
Guidance on medical device clinical trials
New Zealand Medical Device Organisations
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 medical device organisations
Overseas Medical Device Regulators
Links to key medical device regulators from around the world
Page last updated 17 May 2011