Information for Medical Device Suppliers
New Zealand Definitions
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.
Legal Definition of a Medical Device
The legal definition of a medical device is contained in Section 2 of the Medicines Act 1981 and states;
- Medical device means any device, instrument, apparatus, or contrivance, including component parts and
accessories thereof, that is manufactured, imported, sold, or supplied for use wholly or principally on or by one or
more human beings for a therapeutic purpose; and includes bandages and other surgical dressings, except medicated
dressings where the medication has a curative function that is not limited to sterilising the dressing; but does not
- (a) Any ultrasonic therapy apparatus within the meaning of section 2 of the Physiotherapy Amendment Act 1953:
- (b) Except in section 38 of this Act, any irradiating apparatus within the meaning of section 2(1) of the Radiation Protection Act 1965:
- (c) Any article of a kind or belonging to a class that is declared by regulations made under this Act to be a kind or class of article that is not a medical device for the purposes of this Act
Note that the Physiotherapy Amendment Act 1953 has been repealed. The definition contained in section 2 of the Act stated;
- Ultrasonic therapy apparatus means any apparatus employing ultrasonic mechanical vibrations that is capable of being used for the treatment of the human body by way of physiotherapy.
Note that Section 2(1) of the Radiation Protection Act 1965 states;
- Irradiating apparatus means any apparatus that can be used for the production of X-rays or gamma rays or for the acceleration of atomic particles in such a way that it produces a dose equivalent rate of or exceeding 2.5 microsieverts per hour at a point which could be reached by a living human being.
Page last updated 10 May 2011