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Introduction

Suppliers of medical devices should be familiar with these definitions to ensure the products they supply are appropriately regulated. Note that the supply of products as medical devices that are medicines may breach the Medicines Act 1981. The Medicines Act provides the legal definition of the following: therapeutic purpose medicine medical device Organisations and individuals supplying medical devices (sponsors) should be familiar with these definitions to ensure their products are correctly marketed and regulated. See also: Definition of a sponsor Definition of a medical device manufacturer Human tissue products Categorisation of products

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Therapeutic Purpose

A product is regulated as a medical device or a medicine if the manufacturer or sponsor claims or implies a therapeutic purpose for it. Legal Definition of Therapeutic Purpose The legal definition of therapeutic purpose is contained in Section 4 of the Medicines Act 1981 and states: Therapeutic purpose - means any of the following purposes, or a purpose in connection with any of the following purposes: preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; or influencing, inhibiting, or modifying a physiological process; or testing the susceptibility of persons to a disease or ailment; or influencing, controlling, or preventing conception; or testing for pregnancy; or investigating, replacing, or modifying parts of the human anatomy

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Understanding Therapeutic Purpose

The legal definition of therapeutic purpose provides the framework for understanding the concept. Understanding how these clauses apply to medical devices is important to the definition of a medical device. Note that a therapeutic purpose, either claimed or implied, for a product may result in it being determined to be a medicine or a medical device. The following examples are provided for illustrative purposes only. Products with a therapeutic purpose are not limited to these examples. Treating or Preventing Disease Devices that are used primarily for treating or preventing disease include, but are not limited to; Surgical instruments Pacemakers and defibrillators Contact and ophthalmic lenses Dental equipment Surgical laser systems Infusion pumps Diagnosing or Monitoring a Disease This encompasses a wide range of diagnostic medical devices and includes, but is not limited to; In-Vitro Diagnostic (IVD) devices Heart rate monitors Blood pressure cuffs Thermometers Stethoscopes Ultrasound scanners and probes Medical imaging systems Ovulation kits Preventing Conception For medical devices this includes but is not limited to; Condoms Diaphragms Intra-Uterine devices Replacing or Modifying Parts of the Human Anatomy Examples of devices that meet this criteria include; Orthopaedic implants Prosthetics and orthotics Orthodontic devices Influencing, Inhibiting or Modifying a Physiological Process This is a broad range of products that range from sophisticated implantable devices through to products to assist those with disabilities, and include but are not limited to; Gastric banding devices TENS machines Hearing aids CPAP machines and breathing circuits

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Claiming a Therapeutic Purpose

Claiming a therapeutic purpose for a product defines it as a therapeutic product and subject to the requirements of the Medicines Act 1981 and its Regulations. Understanding how the claim of a therapeutic purpose may impact on the regulation of a product will help prevent potential breaches of the legislation. A claim might be overtly made or implied. Therapeutic Claims A claim made for a therapeutic purpose is an indication that the product is regulated by the Medicines Act 1981. A therapeutic purpose can be indicated in many ways, for instance: by the very nature of the device, that is, it can only have a therapeutic purpose by labelling by advertising Note that advertising has a broad meaning in the Medicines Act and captures all forms of written, visual and electronic media and includes anything said about the product. The full description is explained in Section 56 of the Medicines Act 1981. There are certain restrictions on advertising claims that may be made for certain disease states and physiological conditions. It is important to comply with these. These are explained in Section 58 and Schedule 1 of the Medicines Act 1981. Magnetic, Galvanic, Electric, Electronic or Vibratory Forces Regulation 62 of the Medicines Regulations 1984 state; No person shall sell any medical device that is claimed to operate by inducing, concentrating, directing, or producing, or counteracting, screening, or giving protection from, any magnetic, galvanic, electric, electronic, radiation, or vibratory forces or effects unless— Such properties are, before or at the time of sale, quantitatively described to the purchaser in writing in terms that can be measured by scientific physical means; and The medical device demonstrably has the properties claimed and described Therapeutic Advertising Pre-Vetting System The Association of New Zealand Advertisers provides a pre-vetting service for advertisers of therapeutic products. The Therapeutic Advertising Pre-vetting System (TAPS) will review advertising material (including websites) for compliance with the relevant codes and Regulations. Alternatively advertisers may wish to use consultants with experience in therapeutic product advertising to ensure compliance with the legislation and regulations.

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Medicine

Legal Definition of a Medicine means any substance or article that - is manufactured, imported, sold, or supplied wholly or principally for administering to 1 or more human beings for a therapeutic purpose; and achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means; and includes any substance or article - that is manufactured, imported, sold, or supplied wholly or principally for use as a therapeutically active ingredient in the preparation of any substance or article that falls within paragraph (a); or of a kind or belonging to a class that is declared by regulations to be a medicine for the purposes of the Medicines Act; but does not include - a medical device; or any food within the meaning of section 2 of the Food Act 1981; or any radioactive material within the meaning of section 2(1) of the Radiation Protection Act 1965; or any animal food in which a medicine (within the meaning of paragraph (a) or (b)) is incorporated; or any animal remedy; or any substance or article of a kind or belonging to a class that is declared by regulations not to be a medicine for the purposes of the Medicines Act.

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Medical Device

Only products that meet the legal definition of a medical device are regulated as medical devices. Legal Definition of a Medical Device means any device, instrument, apparatus, appliance, or other article that - is intended to be used in, on, or for human beings for a therapeutic purpose; and 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 includes a material that - is intended to be used in or on human beings for a therapeutic purpose; and 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 also includes - 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 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 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.

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Sponsor

The Sponsor is the New Zealand entity - importer, exporter or local manufacturer - that has the legal responsibility for a medical device supplied in New Zealand. This responsibility includes ensuring that medical devices are notified to the WAND database in accordance with the Regulations. Download the WAND New Sponsor Application Form (Microsoft Word document 94 KB) Legal Definition of a Sponsor The legal definition of a sponsor is contained in Regulation 3 of the Medicines (Database of Medical Devices) Regulations 2003 and states; sponsor, in relation to a medical device - means - a person in New Zealand who exports, or arranges the exportation of, the device from New Zealand: a person in New Zealand who imports, or arranges the importation of, the device into New Zealand: 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 does not include a person who - exports, imports, or manufactures a device; or 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 Key Criteria of a Sponsor The interpretation of the above definition establishes the following criteria for a sponsor; A sponsor is based in New Zealand and must has a local presence (registered business or principal place of business in New Zealand) A sponsor imports, exports, or manufacturers medical devices in New Zealand A sponsor may arrange for a New Zealand based third party to manufacture a medical device on its behalf for supply anywhere A sponsor may arrange for an agent to import and distribute a medical device to New Zealand on their behalf. In these instances, the sponsor, and not the agent, has all the responsibilities of a sponsor which are listed below. Note - A sponsor must have a presence in New Zealand. Organisations without a New Zealand presence cannot be sponsors. A sponsor is NOT an individual or organisation that purchases products from a New Zealand based sponsor for resale within New Zealand. Examples of Sponsors A New Zealand entity (individual or organisation) importing devices into New Zealand for sale to the local market A New Zealand hospital directly importing a device from an overseas manufacturer A healthcare professional making a one off importation of a small number of devices, one of which he/she keeps, and reselling the balance A New Zealand entity parallel importing any medical device into New Zealand for sale to the local market A New Zealand entity importing a range of medical devices into New Zealand which it repackages as first aid kits for resale A New Zealand entity contracting a New Zealand third party to produce a first aid kit to the entity's specifications Examples of entities that are NOT Sponsors Overseas companies supplying product directly to New Zealand organisations (The importer is the legal sponsor.) An organisation or individual that purchases medical devices from a sponsor or that purchases medical devices that have been supplied by a sponsor. Responsibilities of a Sponsor A sponsor has the following responsibilities; To ensure that the device is safe for its intended purpose. (Refer Section 38 of the Medicines Act 1981.) To notify information about its medical devices to the WAND database within 30 working days of becoming the sponsor. (Refer Regulation 6 of the Medicines (Database of Medical Devices) Regulations 2003.) To ensure, should the information notified to the WAND database become inaccurate or incorrect, that it is corrected within 10 working days of the information ceasing to be accurate or correct. (Refer Regulation 8 of the Medicines (Database of Medical Devices) Regulations 2003.) To maintain distribution records of the devices supplied so that in the event of a recall or corrective action the sponsor can contact all affected users. (Refer to the Medsafe Uniform Recall Procedure.) To immediately advise Medsafe of any recall or corrective action affecting medical devices supplied by that sponsor in New Zealand. (Refer to the Medsafe Uniform Recall Procedure (PDF 469 KB, 49 pages).) To ensure that the labelling of the medical devices complies with the Regulations. (Refer Regulation 12 of the Medicines Regulations 1984.) To ensure that any advertising for medical devices supplied by that sponsor complies with the requirements of the Medicines Act and Regulations. (Refer Part 4 of the Medicines Act 1981.)

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Medical Device Manufacturer

Individuals and organisations manufacturing medical devices in New Zealand should ensure the devices are correctly notified to the WAND database. Manufacturing includes assembling of kits of medical devices (ie, first aid kits) as well as device fabricators. Definition The Medicines Act 1981 and Medicines (Database of Medical Devices) Regulations 2003 do not provide a definition of a medical device manufacturer. In the absence of an explicit definition, common use of the term would be presumed. The following guidance is provided. manufacturer includes a person or organisation that carries on the business of assembling, producing, or processing goods, and includes - any person or organisation that holds itself out to the public as the manufacturer of the goods: any person or organisation that attaches its brand or mark or causes or permits its brand or mark to be attached, to the goods: First Aid Kits Organisations or individuals in New Zealand that source a variety of products, either from overseas or locally within New Zealand, to assemble and market as first aid kits are manufacturers. They meet the above criteria as the assembler of the kit is attaching their mark (brand) to the goods.