Definition of Medical Device under New Zealand's Medicines Act 1981

1. Primary Definition

Section 2(1) of the Medicines Act 1981 defines a medical device as any instrument, apparatus, appliance, material, or other article (whether used alone or in combination, and including the software necessary for its proper application) intended by the manufacturer to be used for human beings for one or more of the following purposes:

• diagnosis, prevention, monitoring, treatment, or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap
• investigation, replacement, or modification of the anatomy or of a physiological process
• control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp#device

2. Key Exclusions from the Definition

The definition excludes:

• human tissue or cells intended for implantation, transplantation, infusion, or transfer into a human being (these are regulated as medicines under the Act)
• products that achieve their principal intended action by pharmacological, immunological, or metabolic means (these are medicines, not devices)

Additionally, certain software is explicitly excluded from being a medical device if it is intended only to:

• store or transmit data or images for communication or archiving
• display, print, or convert medical images or signals
• provide information for patient management without direct influence on diagnosis or treatment decisions

Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp#device

3. Borderline Products and Accessories

Products that fall on the borderline between medicines and medical devices are assessed case-by-case based on their principal mode of action. If the principal action is pharmacological/immunological/metabolic, the product is a medicine; otherwise, it may be a device. Accessories to medical devices are considered medical devices if they are specifically intended by the manufacturer to be used together with the device to enable it to be used in accordance with its intended purpose. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp#device

4. Intended Purpose and Manufacturer's Claims

The classification and regulation depend heavily on the intended purpose as stated by the manufacturer (e.g., in labelling, instructions for use, promotional materials, or technical documentation). Medsafe considers the claims made about the product when determining whether it meets the definition of a medical device. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp#device

5. Regulatory Implications

Products meeting this definition are regulated as medical devices under the Medicines Act 1981 and the Medicines (Database for Medical Devices) Regulations 2005. They must comply with relevant standards, including conformity assessment requirements for market entry in New Zealand. In vitro diagnostic (IVD) devices are included within this definition when they meet the criteria above. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp#device

This definition aligns closely with international frameworks (e.g., IMDRF and EU MDR), facilitating harmonization for manufacturers seeking access to the New Zealand market. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp#device

6. Additional Notes

The page is part of Medsafe's regulatory guidance on medical devices and was last updated as per the site's content (specific date not indicated in the accessed content). For full context, consult the Medicines Act 1981 and related regulations directly. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp#device