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What is Not a Medical Device?

Overview​

Not every product used in healthcare is a medical device under Australian law. Many products that interact with the human body, or are used in clinical settings, fall outside the regulatory definition and do not require ARTG inclusion. Understanding what is excluded is as important as understanding what is included — incorrectly assuming a product is a medical device leads to unnecessary compliance burden, while incorrectly assuming it is not can lead to serious legal exposure.

Products That Are Not Medical Devices​

Medicines and Biologicals​

Products that achieve their principal intended action through pharmacological, immunological, or metabolic means are regulated as medicines or biologicals — not as medical devices. This is the most important boundary in the therapeutic goods framework. A product can have a physical component and still be regulated as a medicine if its primary action is pharmacological (for example, a drug-eluting stent is regulated as a medical device incorporating a medicine, not as a medicine itself).

Starting Materials​

A starting material is a basic material or component used to manufacture a medical device. It is not itself a medical device because it has not yet been manufactured into a finished product with a specific intended medical purpose. Examples include raw polymers, metals, or chemicals purchased for use in device manufacturing.

Your product is likely a starting material if it:

  • Can be used to manufacture more than one kind of product
  • Does not itself meet the definition of a medical device
  • Cannot be used directly on a patient until a manufacturing process is undertaken

Manufacturing Equipment​

Equipment used in the production of medical devices — such as moulds, assembly tools, or testing instruments used in manufacturing — is not itself a medical device.

General Consumables and Household Products​

A product must have a specific medical intended purpose to be a medical device. General consumer products such as ordinary bandages sold for everyday cuts, general-purpose gloves, or basic thermometers sold for household use without any medical claims may not be medical devices. However, if any medical claims are made in labelling or advertising, the regulatory status changes immediately.

Excluded Software​

Not all software used in healthcare is a medical device. The TGA has defined categories of software that are specifically excluded from regulation as medical devices, even if they are used in clinical settings. Software is generally excluded if it:

  • Does not take data directly from a medical device
  • Is intended only to provide a recommendation to a health professional (not to replace clinical judgement)
  • Is based on established clinical guidelines that can otherwise be independently verified

Examples of excluded software include certain clinical decision support tools that provide alerts based on established drug interaction rules, and administrative hospital software such as bed management systems.

Software that does meet the medical device definition — such as software intended to diagnose a condition, interpret medical images, or monitor a physiological parameter — is regulated as an active medical device.

Personal Protective Equipment (Without Medical Claims)​

PPE such as face masks and respirators may or may not be medical devices depending on their intended purpose and the claims made. A surgical mask intended to protect a patient from the wearer's respiratory emissions during a procedure is a medical device. A dust mask sold for industrial use with no healthcare claims generally is not. If in doubt, check the specific product's labelling and intended use.

Cosmetics and General Wellness Products​

Products intended purely for cosmetic or general wellness purposes — without specific claims to diagnose, treat, prevent, or alleviate a disease or injury — are generally not medical devices. However, if any therapeutic claims are made, the regulatory status changes.

The Boundary Can Be Subtle​

The line between a medical device and a non-regulated product depends almost entirely on the claims made. The TGA can and does take action against products making therapeutic claims without ARTG inclusion. When in doubt:

  1. Review the intended purpose as stated in all labelling and promotional materials
  2. Use the TGA decision tool below
  3. Consider seeking independent regulatory advice

Official Sources​