Medical Device Registration in New Zealand

Legal Definition of a Medical Device

1. means any device, instrument, apparatus, appliance, or other article that –
   1. is intended to be used in, on, or for human beings for a therapeutic purpose; and
   2. does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and
2. includes a material that –
   1. is intended to be used in or on human beings for a therapeutic purpose; and
   2. does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and
3. also includes –
   1. anything that is intended to be used with a device, instrument, apparatus, appliance, article, or material referred to in paragraph (a) or (b) to enable the device, instrument, apparatus, appliance, article, or material to be used as its manufacturer intends; and
   2. any device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations to be a medical device for the purposes of the Medicines Act; but
4. does not include a device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations not to be a medical device for the purposes of the Medicines Act.