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Medicines Act 1981

Dealings with medicines and medical devices - Quality and standards

38: Restrictions on sale of medical devices

You could also call this:

"Rules for Selling Medical Devices Safely"

Illustration for Medicines Act 1981

You need to know what a medical device is. It includes things like irradiating apparatus, which is explained in section 5(1) of the Radiation Safety Act 2016. A medical device is unsafe if it can hurt you or someone else. Two or more medical devices are the same kind if they are similar, used in the same way, and sold for the same purpose. If the Director-General thinks a medical device is unsafe, they can ask the importer or manufacturer to prove it is safe. You have 45 days to give the Director-General evidence that the medical device is safe. The Director-General can ask for more evidence if they are not satisfied. If the Director-General does not check a medical device, it does not mean it is safe. The Director-General can check medical devices at different times and can change their mind if they get new information. If someone sells a medical device that is not safe, they can get in trouble. They might go to prison for up to 6 months or get a fine of up to $5,000. You can get in trouble if you sell a medical device after the Director-General has asked you to prove it is safe, but before they say it is safe.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55446.

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Part 2Dealings with medicines and medical devices
Quality and standards

38Restrictions on sale of medical devices

  1. For the purposes of this section,—

  2. the term medical device includes an irradiating apparatus within the meaning of section 5(1) of the Radiation Safety Act 2016:
    1. a medical device is unsafe if the use of that device may be injurious to the health of the person using it or the person in respect of whom it is used:
      1. 2 or more medical devices shall be deemed to be of the same kind, notwithstanding any minor differences or any difference in any name, if they are—
        1. substantially similar to one another; and
          1. designed to be used in the same way; and
            1. sold for the same therapeutic purpose.

            2. If the Director-General has reason to believe that any medical device may be unsafe, he may, by notice in writing to the importer or manufacturer in New Zealand, state the reasons for his belief, and require the importer or manufacturer to satisfy him of the safety of that medical device.

            3. The importer or manufacturer shall supply to the Director-General, within 45 days after receiving the notice under subsection (2), or such further time as the Director-General may allow, evidence of the safety of the medical device.

            4. If the Director-General is not satisfied, by evidence supplied to him pursuant to a notice under subsection (3) or otherwise of the safety of the medical device, he may at any time, within the period of 45 days following the receipt of that evidence, by a further notice under subsection (2) require the manufacturer or importer to supply him with further evidence of the safety of the medical device.

            5. The fact that the Director-General does not exercise the powers conferred on him by this section in respect of a medical device shall not be deemed to warrant the safety of the medical device.

            6. The Director-General may exercise the powers conferred on him by this section from time to time with respect to different importers or manufacturers of the same kind of medical devices, and the fact that he has not exercised any of those powers in respect of a particular kind of medical device, or that he has informed any person that he is satisfied of the safety of a particular kind of medical device, shall not prevent him from exercising any such power in respect of that kind of medical device where new information comes to his attention.

            7. In any proceedings for an offence against this section in which it is alleged that 2 or more medical devices are of the same kind, it shall be presumed that those medical devices are of the same kind until the contrary is proved.

            8. Every person commits an offence and is liable on conviction to imprisonment for a term not exceeding 6 months or a fine not exceeding $5,000 who,—

            9. having received a notice under subsection (2) and failed to comply with subsection (3), sells the medical device; or
              1. having received a notice under subsection (4), sells the medical device before he has been notified by the Director-General that he is satisfied of the safety of the medical device.

                Notes
                • Section 38(1)(a): amended, on , by section 99 of the Radiation Safety Act 2016 (2016 No 6).
                • Section 38(8): amended, on , by section 413 of the Criminal Procedure Act 2011 (2011 No 81).