Medical products include which of the following
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. Show The Medicines Act provides the legal definition of the following: Organisations and individuals supplying medical devices (sponsors) should be familiar with these definitions to ensure their products are correctly marketed and regulated. See also:Human tissue productsCategorisation of productsTherapeutic PurposeA 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 PurposeThe 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:
Understanding Therapeutic PurposeThe 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 DiseaseDevices that are used primarily for treating or preventing disease include, but are not limited to;
Diagnosing or Monitoring a DiseaseThis encompasses a wide range of diagnostic medical devices and includes, but is not limited to;
Preventing ConceptionFor medical devices this includes but is not limited to;
Replacing or Modifying Parts of the Human AnatomyExamples of devices that meet this criteria include;
Influencing, Inhibiting or Modifying a Physiological ProcessThis 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;
Claiming a Therapeutic PurposeClaiming 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 ClaimsA 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:
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 ForcesRegulation 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—
Therapeutic Advertising Pre-Vetting SystemThe 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. MedicineLegal Definition of a Medicine
Only products that meet the legal definition of a medical device are regulated as medical devices. Legal Definition of a Medical Device
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 SponsorThe legal definition of a sponsor is contained in Regulation 3 of the Medicines (Database of Medical Devices) Regulations 2003 and states;
Key Criteria of a SponsorThe interpretation of the above definition establishes the following criteria for a sponsor;
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
Examples of entities that are NOT Sponsors
Responsibilities of a SponsorA sponsor has the following responsibilities; To ensure that the device is safe for its intended purpose. (Refer Section 38 of the Medicines Act 1981.)
Medical Device ManufacturerIndividuals 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. 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 -
First Aid KitsOrganisations 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. What are the products of medical?Medical Products means all regulated substances, chemicals, compounds, drugs, blood, tissue, organs, serums, organisms or part thereof (including genetic materials), viruses, waste and other materials related thereto and used in connection with medical treatment, laboratory analysis, production or analysis of drugs, or ...
What is an example of a medical device?Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters.
What are medical devices used for?Medical Devices are considered a fundamental component of Health Systems; the benefits they can provide continue to increase as they're essential to prevent, diagnose, treat and rehabilitate illnesses and diseases in a safe and effective way.
How are medical devices classified?Classification of Medical Devices
The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.
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