Australia’s TGA
Medical Devices
The Therapeutic Goods Administration (TGA) is the unit of the Australian government’s Department of Health and Aging that oversees medical device regulation in Australia. Before selling any medical devices in Australia, they must first be registered in the Australian Register of Therapeutic Goods (ARTG).
The registering pathway for medical devices with the TGA depends on their risk classification compliance with quality, safety and performance principles; compliance with regulatory controls for manufacturing processes; listing in the Australian Register of Therapeutic Goods; and post-market vigilance programs.
TGA Medical Device Definition:
A medical device is defined as “any instrument, apparatus, implement, machine, appliance, implant, software, material or other similar or related device (including any diagnostic product for in vitro use) that is intended by the manufacturer to be used, alone or in combination, for human beings for the specific purpose of one or more of the following:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
- investigation, replacement, modification or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- control of conception;
- disinfection of medical devices;
- providing information for medical purposes by means of in vitro examination of specimens derived from the human body; and 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 function by such means.”
Software as Medical Device (SaMD):
An SaMD in Australia is defined as a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
In Vitro diagnostic Device (IVD)
An in vitro diagnostic medical device (IVD) is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.
More Resources:
- TGA website
- Australian Regulatory Guidelines for Medical Devices (ARGMD)
- To access more information click on the ‘ Read More‘ tab.
Pharmaceuticals
The Therapeutic Goods Administration (TGA) is the unit of the Australian government’s Department of Health and Aging that oversees pharmaceutical regulation in Australia. Before selling any pharmaceuticals in Australia, they must first be registered in the Australian Register of Therapeutic Goods (ARTG). Manufacturers must also provide Declarations of Conformity to the Australian Regulations to register with the TGA. Medicines in Australia are risk based and are divided into registered and listed medicines.
Registered Medicines Definition:
Registered medicines are higher risk. Because of this we fully assess all registered medicines for safety, quality and efficacy before they go on sale. Most Registered medicines are either categorized as over-the counter (OTC) or prescription Medicines. Prescription medicine are high risk and are only available to patients via a authorized health professional. OTC medicines are used mostly for mild health problems. Examples include headaches and sore throats.
Listed Medicine Definition:
Listed medicines are lower risk and can be purchased off the shelf from pharmacies, health shops, and supermarkets. Most listed medicines are categorized as a complementary medicine. Examples of complementary medicines are traditional herbal medicines and vitamins and minerals.
TGA Radiopharmaceuticals definition:
Radiopharmaceuticals contain a radioactive component or are intended to be combined with a radioactive component before use. They comprise of:
- ready-for-use radiopharmaceuticals, including Positron Emission Tomography (PET) radiopharmaceuticals
- nonradioactive components (kits and chemical precursors, including those for PET) for combination with a radioactive component (e.g. eluate from a radionuclide generator or a cyclotron-produced radionuclide)
- radionuclide generators
- radionuclide precursors used for radiolabelling other substances before administration.
More Resources:
- To access more information click on the ‘ Read More‘ tab.
- Australian Regulatory Guidelines for Prescription Medication.
- Australian Regulatory Guidelines for Biologics.
Cosmetics
In Australia, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regulates the importation and manufacture of chemicals for ‘industrial’ use, which includes cosmetics and soaps. Chemicals for human therapeutic use, such as medicines, are regulated by the Therapeutic Goods Administration (TGA). Ingredients in cosmetic products, even those described as ‘natural’, are regulated as industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989, which is administered by the NICNAS.
Cosmetic Definition:
A cosmetic is defined as “A substance that is designed to be used on any external part of the human body—or inside the mouth—to change its odors, change its appearance, cleanse it, keep it in good condition, perfume it or protect it.”
Cosmetic or Therapeutic Good?
Some products are used in a similar way to cosmetics but are regulated as therapeutic goods, for example sunscreens. Several factors influence whether a product is a cosmetic or therapeutic good, including:
- the primary use or purpose of the product
- the ingredients in the product and their effects on the body
- how the product is applied and/or administered and
- how the product is promoted, represented, presented or labelled.
There is no single resource or government agency that provides all the information required when researching the cosmetic regulations in Australia, and no check list that covers all elements required to be on a cosmetic product label making the Australian Cosmetic markets complicated to navigate.
More Resources:
- To access more information click on the ‘ Read More‘ tab.
Nutraceuticals
In Australia, medicinal products containing such ingredients as herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations are referred to as ‘complementary medicines’ and are regulated as medicines under the Therapeutic Goods Act 1989 (the Act).
Complementary Medicine Definition:
A complementary medicine is defined in the Therapeutic Goods Regulations 1990 or also known as ‘traditional’ or ‘alternative’ medicines, which include vitamin, mineral, herbal, aromatherapy and homoeopathic products.
Complementary Medicine Categories:
Australia has a risk-based approach with a two-tiered system for the regulation of all medicines. Complementary medicines may be either listed or registered, depending on their ingredients and the claims made. Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG); Higher risk medicines must be registered on the ARTG.
Complementary Medicine Definition:
A complementary medicine is defined in the Therapeutic Goods Regulations 1990 or also known as ‘traditional’ or ‘alternative’ medicines, which include vitamin, mineral, herbal, aromatherapy and homoeopathic products.
Complementary Medicine Categories:
Australia has a risk-based approach with a two-tiered system for the regulation of all medicines. Complementary medicines may be either listed or registered, depending on their ingredients and the claims made.
Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG);
Higher risk medicines must be registered on the ARTG.