Is my product a medical device?

This material is provided by the TGA (a part of the Department of Health) solely to provide a general overview of the TGA regulatory scheme, and particularly to assist small to medium enterprises to better engage with the regulatory scheme. It should not be taken as a detailed description of the scheme or as specific advice on the application of the therapeutic goods legislation in particular cases, nor as a statement of policy.

If you would like further information you should contact the TGA (the TGA website also contains more detailed information on all aspects of the regulatory scheme), or if you need advice on the application of the therapeutic goods legislation in particular cases, you should make your own enquiries to obtain that specific advice.

The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials.

It would appear that your product might not be a therapeutic good as you have indicated it is an excluded good.

If your product is already included in the ARTG and on the basis that your product is not a therapeutic good, you should consider cancelling your entry from the ARTG.  If you choose not to cancel your product at this time, the TGA may investigate the regulatory status of your product in the future and elect to take action to cancel it from the ARTG.

Based on your ‘yes’ response to Questions 1, 2 and 3 and ‘no’ to Question 4, this indicates your product is a medical device, and needs to be included in the ARTG.

You may like to check that your medical device is appropriately classified, using the 'What classification is my medical device?’ decision tool.

Including your product in the ARTG

If your product is a medical device, your next step will be to submit an application to include your product in the ARTG. You can do this through the TGA Business Services (TBS).

1. You will first need to obtain access to TBS and obtain a client identification number. See Getting started with the TGA for more information.
2. You then enter the details of your medical device and fill out the application.
3. Once you submit an application and you have received an ARTG number, you may import, export and supply the product. There are fees associated with an application for a medical device as well as ongoing charges to keep your product in the ARTG- these can be found in the schedule of fees and charges.

Remember that it is the responsibility of the sponsor to ensure the product remains compliant with all relevant legislation at all times.

Where to go for more help

The Australian Regulatory Guidelines for Medical Devices (ARGMD) provides information on the regulation of medical devices in Australia.

You may wish to seek the services of a Regulatory Affairs Consultant to assist you with submitting an application.

You can also contact the Medical Device Information Unit (devices@health.gov.au).

Excluded goods are products which might be considered to be therapeutic goods but which are specifically declared not to be by an Order of the Secretary of the Department of Health.

These include:

• adhesive remover or non-medicated skin cleaner relating to colostomy and ileostomy
• antiperspirant preparation that derives its antiperspirant properties from inorganic salts of aluminium, zinc or zirconium only
• dental bleach or dental whitener
• device for measuring alcohol content in body fluids or exhaled air
• disinfectant or sterilant gas
• drinking water purification and treatment equipment
• ear candle
• hair bleach, hair dye, hair-colorant or hair-perming preparation
• household and personal aids or furniture and utensils for people with disabilities
• incontinence pad, mattress overlay or mattress protector
• menstrual pad (not tampon or menstrual cup)
• sanitisation, environmental control or environmental detoxification equipment
• topical preparation applied to the nails to harden, or deter the biting of, nails
• compressed gas used as a power source for medical devices
• oral hygiene product for the care of the teeth and the mouth (including dentifrices, mouth washes and breath fresheners) that does not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard that, when advertised or presented for supply: (a) the only benefits claimed to result from the use of the product is consequential on improvements to oral hygiene, including for the prevention of tooth decay or the use of fluoride for the prevention of tooth decay; and (b) benefits in relation to such other diseases or ailments, such as gum or other oral disease periodontal condition, are not claimed to result from the use of the product.

You can find further information in the Therapeutic Goods (Excluded Goods) Determination 2018.

It would appear your product might not be a medical device as you have indicated that it does not have an intended use as a medical device.

If your product is already included in the ARTG and on the basis that your product is not a medical device, you should consider cancelling your entry from the ARTG.  If you choose not to cancel your product at this time, the TGA may investigate the regulatory status of your product in the future and elect to take action to cancel it from the ARTG.

It would appear your product might not be a medical device as you have indicated it has a pharmacological, immunological or metabolic action in the body.

Your product may however, be another sort of therapeutic good regulated in another way. You can find more information at Basics of therapeutic goods regulation.

You can also use the ‘Is my product a therapeutic good?’ decision tool to assist you to determine if your product is another kind of therapeutic good.

If your product is already included in the ARTG as medical device, you should consider cancelling your entry from the ARTG.  If you choose not to cancel your product at this time, the TGA may investigate the regulatory status of your product in the future and elect to take action to cancel it from the ARTG.

In line with the intended purpose of a product, the term ‘medical device’ is defined by Section 41BD of the Therapeutic Goods Act 1989 as:

• to diagnose, prevent, monitor, treat or alleviate a disease
• to diagnose, prevent, monitor, treat or alleviate or compensate for an injury or disability
• to investigate, replace or modify the anatomy or a physiological process
• for controlling conception
• an accessory to a device that performs any of the above functions

The intended purpose of your product is determined by the manufacturer of the product and can be based on any one or more of the following:

• the labelling on the main equipment
• the instructions for using the main equipment
• any advertising material relating to the main equipment
• technical documentation describing the mechanism of action of the main equipment.

It would appear your product might not be a therapeutic good.

If your product is already included in the ARTG and on the basis that your product is not a therapeutic good, you should consider cancelling your entry from the ARTG.  If you choose not to cancel your product at this time, the TGA may investigate the regulatory status of your product in the future and elect to take action to cancel it from the ARTG.

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Go back and try again or contact the TGA.

Medical devices:

• are used on humans
• have therapeutic benefits
• generally have a physical or mechanical effect on the body or are used to measure or monitor functions of the body.