Information for Medical Device Suppliers
New Zealand 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.
The Medicines Act 1981 provides the legal definition of the following;
- Therapeutic purpose
- Medicine
- Medical device
Organisations and individuals supplying medical devices (sponsors) should be familiar with these definitions to ensure their products are correctly marketed and regulated.
Explanation of Therapeutic Purpose
Explanation of a Medicine
Explanation of a Medical Device
Products that are Medicines in New Zealand
Penalties for Supply of Unconsented Medicines
Human Tissue Products
Explanation of Therapeutic Purpose
A product is regulated as a medical device or a medicine if the manufacturer or sponsor claims or implies a therapeutic purpose for it. The definition of therapeutic purpose is in Section 4 of the Medicines Act 1981.
Explanation of Therapeutic Purpose
Explanation of a Medicine
Some products that are considered to be medical devices by other regulators are regulated as medicines in New Zealand. Sponsors of medical devices need to be aware of these differences and ensure that their products follow the correct regulatory pathway. The definition of a medicine is contained within Section 3 of the Medicines Act 1981.
Explanation of a Medical Device
Only products that meet the legal definition of a medical device are regulated as medical devices. Some products that can be marketed as medical devices in other countries are regulated as medicines in New Zealand. Sponsors supplying unapproved medicines as medical devices may be subject to prosecution.
Explanation of a Medical Device
Products that are Medicines in New Zealand
Some products that are considered to be medical devices by other regulators may be medicines in New Zealand as a consequence of the legal definitions contained within the Medicines Act 1981. Sponsors supplying medicines as medical devices may be subject to prosecution. It is the sponsor's responsibility to ensure that its products have been correctly categorised and submitted through the proper regulatory pathway.
A summary of products that are Medicines
Penalties for Supply of Unapproved Medicines
It is important to ensure that products considered to be medicines in New Zealand are not supplied as medical devices. Medicines (with a few, tightly controlled exemptions) must first undergo an approval process which is operated by Medsafe. Approval means that the Minister of Health has given consent to the sale, distribution and advertising of the medicine. A medicine that has not been approved is known as a 'new medicine' and cannot be freely sold, distributed or advertised.
Information about the Penalties for Supply of Unapproved Medicines
Human Tissue Products
Products that contain human tissue may be impacted by the Human Tissue Act 2008. Should a product contain human tissue cells the potential sponsor should ensure that the product is supplied in compliance with this Act.
Summary of the Human Tissue Act 2008 [1-6]
Page last updated 17 May 2011