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Medical Devices

Definition of Medical Device

The following definitions have been extracted from the Medicines Act 1981 and the Medicines (Database of Medical Devices) Regulations 2003.  You can view a full copy of the legislation at www.legislation.govt.nz.

Medical Device
Therapeutic Purpose
Sponsor

“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 include-

1. Any ultrasonic therapy apparatus within the meaning of section 2 of the Physiotherapy Amendment Act 1953:
2. Except in section 38 of this Act, any irradiating apparatus within the meaning of section 2 (1) of the Radiation Protection Act 1965:
3. 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 purpose of this Act:

Meaning of “Therapeutic purpose”- In this Act, unless the context otherwise requires, the term “therapeutic purpose” means-

1. Treating or preventing disease; or
2. Diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition; or
3. Effecting contraception; or
4. Inducing anaesthesia; or
5. Altering the shape, structure, size, or weight of the human body; or
6. Otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way; or
7. Cleaning, soaking, or lubricating contact lenses.

"Sponsor", in relation to a medical device,—

1. means—
    
   1. person in New Zealand who exports, or arranges the exportation of, the device from New Zealand:
   2. person in New Zealand who imports, or arranges the importation of, the device into New Zealand:
   3. a person in New Zealand who manufactures the device in New Zealand, or arranges for another person to manufacture the device in New Zealand, for supply (whether in New Zealand or elsewhere); but
       
2. does not include a person who—
    
   1. exports, imports, or manufactures a device; or
   2. arranges for the exportation, importation, or manufacture of a device,—

on behalf of another person who, at the time of the exportation, importation, manufacture, or making of the arrangements, is a resident of, or is carrying on business in, New Zealand