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Medicines Act 1981

3A: Meaning of medical device

You could also call this:

"What is a medical device?"

Illustration for Medicines Act 1981

In the Medicines Act 1981, a medical device is something used on or for people to help them. It is used for a therapeutic purpose, which means to treat or prevent a disease. You can find more information about the Medicines Amendment Act 2013 at the New Zealand legislation website. A medical device does not work by using medicine or changing the way your body works. It can be helped by medicine, but that is not its main way of working. A medical device can be an object, or a material, or something used with an object or material. Some things are declared by regulations to be medical devices, and some are not. You can check the regulations to see what is included or not included as a medical device.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM6186051.

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3AMeaning of medical device

  1. In this Act, unless the context otherwise requires, medical device—

  2. 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
      1. 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
          1. 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. 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
              1. 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 this Act; but
              2. 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 this Act.

                Notes
                • Section 3A: inserted, on , by section 6 of the Medicines Amendment Act 2013 (2013 No 141).