In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). The TGA administers the Therapeutic Goods Act 1989 (Cth) (TG Act), Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) and Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (Medical Devices Regulations).

The regulatory framework can be split according to the three phases in the life cycle of the medical device:

• Pre-market assessment – the sponsor (as the person legally responsible for supplying the device in Australia) must first apply to the TGA for a preliminary assessment. To pass the preliminary assessment, the sponsor must satisfy certain requirements, including obtaining a conformity assessment certification from the TGA or comparable overseas regulator. This certification demonstrates that the manufacturer has applied appropriate conformity procedures and that the medical device meets the safety, quality and performance standards contained in the Essential Principles (see 2.1 Design and Manufacture). For very low-risk devices, the sponsor can self-certify that the product meets the Essential Principles. An application that passes the preliminary assessment will then proceed to the decision for inclusion on the Australian Register of Therapeutic Goods (ARTG) or audit by the TGA. 
• Market authorisation – after the TGA determines that the medical device meets regulatory requirements, it is included on the ARTG. All medical devices must be included on the ARTG before they can be lawfully sold in Australia. The ARTG is a public searchable register of therapeutic goods that can be legally supplied in Australia.
• Post-market monitoring – after the medical device is included on the ARTG and made available on the market, the TGA continues to monitor the safety and performance of the device. The sponsor must demonstrate continuing compliance with all regulatory, safety and performance requirements and standards. This includes mandated reporting by the sponsor in certain circumstances, including the occurrence of adverse events, overseas regulatory actions and results of investigations undertaken by the manufacturer.

Some devices are excluded from regulation, whilst others are exempt. An “excluded” product means that it is not considered to be a medical device and is not subject to any regulatory requirements under the TG Act. An “exempt” product is one that is subject to some regulatory requirements – this generally means that the product is not required to be included on the ARTG, but is still subject to some oversight by the TGA.

The degree of scrutiny taken by the TGA in its assessment of the medical device depends on its risk classification – a medical device with a higher risk classification level will be subject to a higher level of regulatory oversight.

In general, the classification will depend on the intended purpose of the medical device. Other considerations include:

• the degree of invasiveness in the human body;
• the duration and location of use; and
• whether the device relies on a source of energy other than the body or gravity.

The classification levels, reflecting a risk level from lowest to highest, are as follows:

• Class I – these devices have a low-risk level, with examples including surgical retractors and tongue depressors; this class can be further classified into the following two classification levels:
1. Class Is (supplied sterile) – examples include sterile surgical gloves and hypodermic noodles; and
2. Class Im (with a measuring function) – examples include medicine cups with specific units of measurement.
• Class IIa – these devices have a low to moderate risk level, with examples including dental drills, ultrasound machines, and digital or infrared thermometers.
• Class IIb – these devices have a moderate to high-risk level, with examples including surgical lasers and diagnostic X-rays.
• Class III – these devices have a high level of risk, with examples including prosthetic heart valves, absorbable surgical sutures, hip prostheses and pacemakers. This class also includes Active Implantable Medical Devices such as implantable defibrillators.

Following the release of the TGA’s An Action Plan for Medical Devices (Action Plan) in April 2019, the TGA has been gradually introducing regulatory changes, including in relation to software-based medical devices and Software as a Medical Device (SaMD).

In February 2021, regulations were introduced to classify software-based medical devices according to their potential to cause harm through the provision of incorrect information. The classification rules apply to software-based devices that:

• provide a diagnosis or screen for a disease or condition;
• monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition;
• specify or recommend a treatment or intervention; or
• provide therapy through the provision of information.

As with medical devices in general, SaMD are classified according to the four-tier classification system.

Certain types of software have been excluded from regulation by the TGA (Therapeutic Goods (Excluded Goods) Determination 2018). Such software includes those that are limited to performing a certain function such as:

• software intended to self-manage an existing disease or condition that is not serious (and does not provide specific treatment or treatment suggestions);
• behavioural or coaching software intended to improve general health or wellness factors (eg, weight, exercise, sun exposure, dietary intake) that does not provide information to the consumer that would generally require intervention by a health professional;
• software intended to be used as digital mental health tools based on established clinical practice guidelines; and
• software intended to provide patient alerts or information to health professionals, who can then exercise their own judgement in determining next steps.

Some clinical decision support software (CDSS) are also excluded from regulation pursuant to Item 2.15, Part 2 of Schedule 4 to the Medical Devices Regulations.

Personal Protective Equipment

Personal protective equipment is regulated by the TGA as a medical device if it is intended to be:

• used to prevent the transmission of disease between people; or
• for therapeutic use, such as surgical, clinical, or medical use, or use in other health services.

The Therapeutic Goods (Medical Devices–Specified Articles) Instrument 2020 specifies classes of articles, including personal protective equipment, that are medical devices. 

Medical Instruments

Medical instruments are generally considered to be medical devices.

Cosmetics

Cosmetics are only regulated by the TGA if therapeutic claims are made in relation to the particular product.

For example, sunscreens (being both primary sunscreens and some secondary sunscreens such as moisturisers with an SPF of 15+) are classified as a therapeutic good and must meet all legal requirements, including being included on the ARTG, before being supplied to Australia. Sunscreens must comply with the testing and labelling requirements set out in Australian/New Zealand Sunscreen Standard (AS/NZS) 2604 Sunscreen products – Evaluation and classification.

Cosmetics in respect of which no therapeutic claims are made are regulated by the Australian Industrial Chemicals Introduction Scheme (AICIS) under the Industrial Chemicals Act 2019 (Cth) (IC Act).

Under the IC Act, cosmetics means “a substance or preparation intended for placement in contact with any external part of the human body, including the mucous membranes of the oral cavity and the teeth with a view to altering the odours of the body, changing its appearance, cleansing it, maintaining it in good condition, perfuming it or protecting it.”

An entity that manufactures or imports cosmetics into Australia, other than for personal use, must register its business with AICIS if it imports:

• ready-made cosmetics, unless the cosmetics are for personal use; this applies even if some or all of the ingredients claim to be natural or organic because most cosmetics contain other ingredients that are classed as industrial chemicals under the IC Act; and
• essential oils, carrier oils, fragrance or base ingredients from overseas to mix or blend commercially with its cosmetics.

Importers of cosmetic products into Australia must check each ingredient of their product against the AICIS chemical database which lists chemicals classified in accordance with the reporting and regulatory obligations attached to the chemicals. At the end of each registration year, the business is required to submit a declaration detailing the industrial chemicals imported or introduced into Australia for that registration year.

Additionally, all suppliers of cosmetics must comply with the Australian Competition and Consumer Commission’s (ACCC) mandatory standard for cosmetics ingredients labelling.

Cosmetic products must also comply with the requirements set out in the Standard for the Uniform Scheduling of Medicines and Poisons (Poisons Standard). The Poisons Standard sets out a uniform approach to control the accessibility of substances used in cosmetics, as well as medicines, cosmetics, agricultural products or household cleaners.

Biocides

Biocides are generally considered to be medical devices and thus regulated under the TG Act. In addition to the TG Regulations and Medical Devices Regulations, biocides must also comply with the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 and Poisons Standard.

The regulatory requirements applicable to biocides depend on the intended purpose of the biocide. Products that make specific claims, that is, claims of biocidal activity (eg, virucidal, sporicidal, fungicidal) must be included on the ARTG. In contrast, claims of general antibacterial activity against vegetative bacteria (excluding mycobacteria) or bacteria of the same genus, known as non-specific claims, do not need to be included on the ARTG.

Insecticides and insect repellents must be approved and registered by the Australian Pesticides and Veterinary Medicines Authority (AVPMA) under the Agricultural and Veterinary Chemicals Act 1994 (Cth) and the Agvet Code contained in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) before being sold in Australia.

Food (Including Gene-Edited Products, or GMOs) and Nutrition Supplements

Food

The regulation of food has been standardised across the Australian States and Territories, as well as New Zealand under the Australia New Zealand Food Standards Code (Food Standards Code).

The Food Standards Code prescribes minimum standards in relation to food sold or prepared in Australia including:

• food safety standards;
• primary production standards;
• requirements surrounding labelling, microbiological limits, contaminants and residues; and
• specific standards applicable to food products including infant formula, meal replacement and supplementary food.

Genetically modified foods

All genetically modified foods or ingredients sold in Australia must undergo a safety assessment by Food Standards Australia and New Zealand (Standard 1.5.2 of the Food Standards Code). Furthermore, all genetically modified foods and ingredients that contain new DNA or novel protein, or have an altered characteristic when compared with the counterpart non-genetically modified food (eg, soybeans with increased oleic acid content), must be labelled with the words “genetically modified”. Approved genetically modified foods are listed in Schedule 26 of the Food Standards Code. The release of genetically modified organisms is overseen by the Office of the Gene Technology Regulator under the Gene Technology Act 2000 (Cth).

Nutrition supplements

Vitamins are regulated by the TGA as medicines under the TG Act. Depending on the vitamin and dose, vitamins are categorised as either prescription medicines or complementary medicines. The majority of vitamins sold in Australia are classified as low-risk complementary medicine and are regulated by the TGA for their safety and quality. See 1.3 Medicines on the regulation of medicines.

The Therapeutic Goods (Declared Goods) Order 2019 declares certain supplements, other than vitamins, to be regulated as medicines under the TG Act: 

• goods that are or contain Cellasene;
• goods that contain fibre and are manufactured in the dosage form of a tablet, capsule or pill;
• goods that contain or are promoted to contain isolated b-hydroxy-b-methylbutyrate (HMB) or its salts and are manufactured in the dosage form of a tablet, capsule or pill; and
• goods that contain shark cartilage and are manufactured in the dosage form of a tablet, capsule or pill or a powder where that powder is not a wholesale product for use as an ingredient in food.

Formulated meal replacements, formulated supplementary foods and formulated supplementary sports foods are regulated under Standards 2.9.3 and 2.9.4 of the Food Standards Code.

In Australia, therapeutic goods, including pharmaceuticals and biologicals, are regulated by the TGA. The legal requirements are primarily set out in the TG Act and TG Regulations.

Pharmaceuticals

All medicines supplied in Australia must be included on the ARTG. Depending on the risk, medicines will be either listed or registered on the ARTG.

Listed medicines have a lower risk compared to registered medicines. There are two types of listed medicines:

• Listed medicines – these medicines, which must contain a “AUST L” number on the label, present the least risk. The TGA only allows listed medicines to contain pre-approved low-risk ingredients and only low-risk claims may be made in respect of them.
• Assessed listed medicines – these medicines, which must contain an “AUST L(A)” number on the label, can have slightly higher risk health claims made in respect of them compared to other listed medicines. As a result, the health claims and product indication for assessed listed medicines must be reviewed by the TGA prior to being supplied in Australia.

Registered medicines, which must have an “AUST R” number on the label, have a higher risk. The TGA assesses all registered medicines for their safety, quality and efficacy.

All medicines, regardless of whether they are listed or registered, must be manufactured in a licensed or approved facility in accordance with GMP, except for its Annexes 4, 5 and 14, which are not adopted by Australia (see Therapeutic Goods (Manufacturing Principles) Determination 2020). Manufacturers of medicines in Australia are required to have a manufacturing licence. Overseas manufacturers of medicines must obtain GMP clearance via either the Mutual Recognition Agreement or Compliance Verification pathways, or, if this is not possible, GMP Certification by the TGA following a successful on-site inspection.

The availability of a substance to be used as an ingredient in medicines is regulated by the Poisons Standard. Under the Poisons Standard, medicines and chemicals are classified into Schedules according to the level of regulatory control over their availability and are given legal effect through State and Territory legislation as follows:

• Schedules 2 (Pharmacy Medicine), 3 (Pharmacy Only Medicine), 4 (Prescription Only Medicine) and 8 (Controlled Drug) include medicinal substances intended for human use, with those scheduled in higher numbers subject to a higher level of regulatory control on their availability, including a higher degree of professional healthcare intervention.
• Schedule 9 includes the substances that have a high likelihood of abuse and are only available for the purposes of analysis and medical or scientific research, including clinical trials, conducted with the approval of the Commonwealth and/or State/Territory health authorities.
• Substances included on Schedules 5 (Caution), 6 (Poison) and 7 (Dangerous Poison) include poisons with increasing regulatory controls over their availability and access as well as increasingly stricter container and labelling requirements.
• Schedule 10 (Substances of such danger to health as to warrant prohibition of sale, supply and use) includes substances which are prohibited outright.

Blood Products

Blood, blood components and plasma derivatives are regulated under the TG Act.

Under the TG Act, blood is defined as whole blood extracted from human donors and “blood components” mean therapeutic components that have been manufactured from blood (including red cells, white cells, progenitor cells, platelets and plasma). The TG Act does not include products derived through fractionation of plasma in the definition of blood components.

A manufacturer of blood or blood components must obtain a license under Part 3-3, Section 36(1) of the TG Act. Manufacturers of blood and blood components must comply with the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013 and in a manner that is consistent with the relevant Technical Master file lodged by the manufacturer with the TGA.

However, exemptions from TGA oversight apply to blood and blood components:

• collected by a medical practitioner in the course of providing medical treatment for the purpose of diagnosis of, or testing for, a medical condition;
• manufactured by a medical practitioner for therapeutic application to a patient who is under the practitioner’s care; and
• manufactured by a blood collection centre for a medical practitioner for therapeutic application to a patient who is under the practitioner’s care.

Plasma derivatives are treated as prescription medicines under the TG Act. Sponsors of plasma derivatives are required to obtain a license for the manufacture of plasma derivatives and apply for inclusion of the product on the ARTG.

Relevant standards applicable to the manufacture of blood, blood components and plasma derivatives include:

• Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017; and
• Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019.

Psychedelics

MDMA and psilocybin are included in Schedule 9 of the Poisons Standard as Prohibited Substances. The lawful supply of products containing these psychedelics has been largely limited to clinical trial settings only.

Since 1 July 2023, MDMA and psilocybin have been scheduled down to a Schedule 8 Controlled Drug when used under certain conditions. Only authorised psychiatrists can prescribe products containing MDMA or psilocybin for specific mental health conditions through the Authorised Prescriber Scheme (APS). The APS is one of the pathways through which unapproved therapeutic goods may be accessed by consumers outside of clinical trial settings.

Importers or manufacturers of MDMA and psilocybin products must obtain the necessary licenses and permits from the TGA and the Office of Drug Control before importing or manufacturing MDMA or psilocybin for supply to an authorised prescriber.

The sponsor of the unapproved therapeutic good is also responsible for ensuring that the prescriber has met the requirements before releasing the unapproved medicine, including that the prescriber has obtained an approval letter from the TGA.

The sponsor is also required to report to the TGA:

• every six months on the quantity of each unapproved product supplied under the APS; and
• serious and unexpected adverse reactions within 15 days.

Cannabidiol (CBD) When Used for Medicinal Purposes

Most medicinal cannabis products have not been assessed by the TGA for safety, quality or effectiveness, and thus are unapproved medicines. It is generally unlawful for a sponsor to supply an unapproved medicinal cannabis product. However, the TGA provides pathways for registered healthcare professionals to access medicinal cannabis for the treatment of their patients.

Certain registered health practitioners may import and/or supply unapproved medicinal cannabis products under either the Special Access Scheme (SAS) or APS.

The sponsor of the medicinal cannabis product bears the onus of ensuring that:

• an exemption, approval or authorisation under either the SAS or APS has been established prior to releasing the therapeutic good;
• their product complies with the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017, which sets out the minimum quality standard for all medicinal cannabis products imported into and supplied or manufactured in Australia; and
• they report to the TGA every six months on the quantity of each unapproved product supplied under the SAS and APS.

The TGA has also categorised medicinal cannabis products based on the proportion of cannabidiol content compared with the total cannabinoid content of the medicine. Sponsors must self-assess and report to the TGA on the category that their medicinal cannabis product falls in. The categories are designed by the TGA to assist prescribers in prescribing and supplying medicinal cannabis products according to their active ingredient.

Broadly, these categories of medicinal cannabis products are as follows:

• Category 1: CBD medicinal cannabis products wherein cannabidiol comprises 98% or more of the total cannabinoid content of the medicine and are listed in the Poisons Standard as Schedule 4 Prescription Only medicines.
• Category 2: CBD-dominant medicinal cannabis products wherein cannabidiol derived from cannabis comprises 60% or more of the medicine and less than 98% of the total cannabinoid content of the medicine and are listed in the Poisons Standard as Schedule 8 Controlled Drugs.
• Category 3: balanced medicinal cannabis products where cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine and are listed in the Poisons Standard as Schedule 8 Controlled Drugs.
• Category 4: THC-dominant medicinal cannabis where other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise 60% or more and 98% or less of the total cannabinoid content of the medicine and are listed in the Poisons Standard as Schedule 8 Controlled Drugs.
• Category 5: THC medicinal cannabis product where cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise more than 98% of the total cannabinoid content of the medicine and are listed in the Poisons Standard as Schedule 8 Controlled Drugs.

Clinical Trials

Clinical trials are regulated under the TG Act and TG Regulations. There are two schemes under which an unapproved therapeutic good can be supplied for the purpose of a clinical trial:

• The Clinical Trials Notification (CTN) Scheme – this scheme is designed for lower-risk treatments where the safety is known. This involves a notification process whereby the Australian sponsor notifies the TGA of its intent to sponsor a clinical trial involving an unapproved therapeutic good. The sponsor must ensure that all relevant approvals are given. The relevant human research ethics committee (HREC) is responsible for undertaking the scientific and ethical review.
• The Clinical Trials Approval (CTA) Scheme – this involves an approval process by the TGA, and is generally designed for high-risk or novel treatments where there is little to no knowledge of safety. The sponsor first submits an application for evaluation by the TGA. The TGA is responsible for evaluating summary information about the product. The HREC is responsible for considering the scientific and ethical issues. Once the unapproved therapeutic good has been approved for use in a clinical trial, the sponsor must then notify the TGA of both the commencement and the completion of each clinical trial.

The conduct of clinical trials is governed by several guidelines as well as other legislation, including:

• ICH Guideline for Good Clinical Practice (CPMP/ICH/135/95);
• National Statement on Ethical Conduct in Human Research 2007 (updated 2018) (National Statement);
• Australian Code for the Responsible Conduct of Research 2018; and
• Privacy Act 1988 (Cth), which regulates the collection, use and disclosure of personal information and “sensitive” information (such as medical information) which may be involved during a clinical trial.

Medical Apps

Medical apps are regulated to the extent that they meet the definition of a medical device under the TG Act. See 1.1 Medical Devices.

Telemedicine

Technologies that enable telemedicine consultations are regulated to the extent that they meet the definition of a medical device under the TG Act. See 1.1 Medical Devices.

In general, communication software that enables telehealth consultations, including the transmission of patient information, for the purposes of supporting the delivery of health services, are excluded from regulation by the TGA under Item 14F of the Therapeutic Goods (Excluded Goods) Determination 2018.

Wearables

As above, wearables are only regulated by medical devices legislation to the extent that they meet the definition of a medical device under the TG Act. See 1.1 Medical Devices.

Wearables are otherwise generally classed as a consumer good and are subject to compliance with requirements under the Australian Consumer Law (ACL), including regarding product safety and fitness for purpose.

Stem Cells

Stem cells and stem cell treatments are regulated as “biologicals” under the TG Act, and therefore must be included on the ARTG before being supplied in Australia. However, autologous stem cell treatments (ie, where the cells have been removed from and then re-applied to the same person) are excluded from regulation (see Therapeutic Goods (Excluded Goods) Determination 2018). 

All biologicals must first be classified according to the level of risk to patients associated with their use. Similar to the classification levels used in relation to medical devices, there are four classification levels in relation to biologicals, from Class 1 (very low risk) to Class 4 (high risk). However, pluripotent stem cells and pluripotent stem cell treatments are generally classed as Class 4 biologicals. Stem cell treatments with multipotent potential will be treated as Class 3 (medium risk) biologicals as they generally have lower safety concerns compared to pluripotent stem cells.

The supply of stem cell products in Australia is subject to compliance with standards regulated by the TGA.

A therapeutic good is defined in the TG Act as a good that is represented in any way to be, or that is, whether because of the way in which the good is presented or for any other reason, likely to be taken to be:

• (i) for therapeutic use;
• (ii) for use as an ingredient or component in the manufacture of therapeutic goods; or
• (iii) for use as a container or part of a container for goods of the kind referred to in (i) and (ii) above.

A therapeutic use is defined in the legislation as use in or in connection with:

• preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons;
• influencing, inhibiting or modifying a physiological process in persons;
• testing the susceptibility of persons to a disease or ailment;
• influencing, controlling or preventing conception in persons;
• testing for pregnancy in persons; or
• the replacement or modification of parts of the anatomy in persons.

Some products that meet the legislative definition of a therapeutic good are exempt or excluded from some (but not all) regulatory requirements. These products are generally considered to be low-risk and are not required to be included on the ARTG. However, they are still subject to other applicable requirements, including requirements to comply with product quality, labelling and packaging standards, advertising requirements, as well as TGA recall provisions.

For example, nappy rash products which were previously categorised as listed medicines and Class I medical devices, are exempted from the requirement to be included on the ARTG. However, these products remain subject to other regulatory requirements, such as compliance with TGA recall provisions.

Subject to exemptions or exclusions, any goods which claim to have a therapeutic use or which otherwise meet the legislative definition of a therapeutic good will be regulated by the TGA.

Australian manufacturers of therapeutic goods must obtain a manufacturing license from the TGA. Sponsors of therapeutic goods that are manufactured overseas must obtain (on the manufacturer’s behalf) GMP clearance or GMP certification.

The sponsor of a therapeutic good is responsible for ensuring that the therapeutic good complies with all relevant legal and regulatory requirements. Whilst manufacturers of therapeutic goods may be located in Australia or overseas, the sponsor must be either:

• a resident in Australia; or
• an incorporated body in Australia conducting business in Australia where the representative of the company is residing in Australia.

Medical Devices

All medical devices listed on the ARTG must comply with the Essential Principles contained in Schedule 1 of the Medical Devices Regulations. The three pillars of the Essential Principles are that the manufacturer must:

• design and construct the medical device according to safety principles and risk mitigation;
• develop solutions that are state-of-the-art and best practice; and
• ensure that the benefits of the medical device outweigh the risks.

Before a medical device is introduced to the market, the sponsor must submit evidence of the medical device’s compliance with the Essential Principles for conformity assessment. There are three ways to certify a medical device’s conformity with the Essential Principles:

• conformity assessment certification issued by the TGA;
• conformity assessment certification issued by an Australian conformity assessment body; or
• conformity assessment documentation issued by a comparable overseas regulator.

The sponsor of a medical device has ongoing obligations to:

• maintain evidence to demonstrate the application of appropriate conformity assessment principles and evidence to demonstrate compliance with all applicable Essential Principles;
• notify the TGA or sponsor as soon as practicable after becoming aware of information relating to:
1. any malfunction or deterioration in the characteristics or performance of the device;
2. any inadequacy in the design, production, labelling or “Instructions for Use” of the device;
3. any use of the device (whether or not intended by the manufacturer) that might lead to the death of a user of the device in Australia, or to a serious deterioration or serious injury to their state of health; and
4. any technical or medical reason for a malfunction or deterioration that has led the manufacturer to take steps to recall devices;
• systematically review information gained after the device was supplied in Australia; and
• undertake appropriate action in relation to post-market complaints or signals.

Medicines and Biologicals

Australian manufacturers of therapeutic goods, excluding medical devices, must obtain a manufacturing license from the TGA. Sponsors of therapeutic goods that are manufactured overseas must obtain (on the manufacturer’s behalf) GMP clearance or GMP certification.

Medicines and biologicals must be manufactured in compliance with GMP principles. Different codes of GMP apply to different types of therapeutic goods:

• Good Manufacturing Practice for Medicines (this also applies to the manufacturing of biologicals that contain live animal cells, tissues or organs); and
• Good Manufacturing Practice for Human Blood and Tissues.

Both sponsors and manufacturers are expected to report potential or known “GMP compliance signals” (that is, alerts to non-compliance of GMP) at their manufacturing sites and provide this information to the TGA. Examples of GMP compliance signals include concerns that there is a potential or actual breach of GMP for medicines, blood or biologicals, particularly where this may lead to a risk to products, and any regulatory actions by an authority in relation to the manufacturing site.

Manufacturer GMP Inspection

To ensure compliance with GMP standards, the TGA regularly conducts inspections of the manufacturer sites. The TGA applies a risk-based approach that takes into account the intrinsic risks associated with the product and manufacturing process as well as the manufacturer’s compliance history to determine the frequency of manufacturer inspections.

Approximately two to four 4 weeks before the date of inspection, the TGA will provide notice to the manufacturer of the impending inspection and will request information relevant to the planned inspection. During the inspection, the TGA’s inspectors will review the manufacturer’s Quality Management System, manufacturing area and personnel involved in the manufacture of therapeutic goods. This may involve interviewing relevant personnel.

Within four weeks following the inspection, the TGA will issue to the manufacturer a letter identifying any deficiencies in the manufacturing process of the therapeutic good. The manufacturer has four weeks to provide a response to this deficiency notice outlining any corrective action that will be taken.

Overseas manufacturers of therapeutic goods supplied to Australia are also required to meet an acceptable standard of GMP. Where a recognised international regulator has approved a manufacturer, the TGA may decide not to inspect the overseas manufacturing site. 

There are no specific obligations in respect of corporate social responsibility, the environment and sustainability that specifically apply to medical devices and consumer health products.

The ACCC has announced that the regulation of greenwashing is an important enforcement priority for it in 2023/2024. Any environmental or sustainability claims made in relation to such products, for example, on the packaging and in advertisements, must not be false or misleading in contravention of the ACL. The ACCC has published draft guidance for businesses making environmental and sustainability claims, which outlines best practices for businesses to ensure they do not fall foul of the ACL when making ESG claims. 

Specific environmental protection legislation may apply to certain components or processes, but these are not specific to therapeutic goods.

In addition to the general provisions under the ACL, which is contained in Schedule 2 of the Competition and Consumer Act 2010 (Cth) (CCA), which prohibit the false or misleading advertising of products, the advertising of medical devices must also comply with the requirements set out in the TG Act and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Advertising Code).

Under the Advertising Code, advertisements about therapeutic goods must:

• be accurate, balanced, not misleading and only contain substantiated claims; these claims must be consistent with the intended purpose of the product as recorded on the ARTG;
• not present the product as being safe or effective in all cases, and must not cause alarm or distress, or encourage inappropriate use;
• refer to scientific or clinical literature in a way that is consistent with the broader body of evidence relating to the product, is easily understood by consumers, clearly identifies the researcher and financial sponsor (where the advertiser should reasonably know that information), and that allows the audience to access the study or research; and
• generally not target children under the age of 12 years.

All advertisements for medical devices must include the following mandatory information:

• either of the two following mandatory statements (displayed or communicated in a prominent manner):
1. “ALWAYS FOLLOW THE DIRECTIONS FOR USE”; or
2. “ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE”.
• the trade name of the device;
• an accurate description of the device; and
• one or more accepted intended purposes for the device.

The Advertising Code prohibits the use of “restricted” and “prohibited” representations in an advertisement for a therapeutic good unless the advertiser has been granted permission by the Secretary for the Minister of Health to make such representations in advertisements for the therapeutic good. Restricted representations refer to a “serious form” of a disease or condition. Prohibited representations refer to the diseases or conditions listed in Schedule 2 of the TG Regulations such as references to cancer, HIV/AIDS and COVID-19.

Additionally, under the Advertising Code and TG Act:

• An endorsement must not be given by:
1. a government or government authority or its employees;
2. a hospital or healthcare facility or its employees, other than a community pharmacy;
3. a current or former health practitioner, health professional or medical researcher;
4. a person who represents themselves as being qualified or trained to diagnose, treat or prevent disease, ailment, defect or injury in persons; or
5. an organisation that represents the interests of healthcare consumers, health practitioners, health professionals or medical researchers unless the advertisement discloses the name of the organisation and whether the organisation has received, or will receive, any valuable consideration for the endorsement.
• The Advertising Code prohibits any person who is engaged in the production, marketing or supply of the therapeutic goods from making a testimonial about the therapeutic goods, including influencers and any person who has, or will receive, valuable consideration for making the testimonial.

See 2.1 Design and Manufacture.

The TGA has mutual recognition agreements with countries to facilitate trade and market access of therapeutic goods as well as mutual recognition of GMP inspection outcomes of medicine manufacturers within the borders of each partner country. Manufacturers or sponsors of a therapeutic good that has marketing authorisation in a recognised jurisdiction can expedite their application for GMP certification or clearance with the TGA. These manufacturers or sponsors may also be exempt from the TGA’s manufacturer GMP inspection activity.

Currently, the TGA has mutual recognition agreements with the equivalent regulatory authority in the European Union, United Kingdom, Singapore and New Zealand. The TGA has a cooperative agreement with the US FDA regarding the exchange of information on current GMP Inspections of Human Pharmaceutical Facilities. Manufacturers or sponsors of a therapeutic good that is regulated by the US FDA can apply for GMP clearance with the TGA using the expedited compliance verification pathway.

Post-Market Surveillance Obligations

The manufacturer of a therapeutic good is responsible for investigating, establishing risk management procedures and taking corrective and preventative actions in relation to their medical devices.

Sponsors must make the initial report of all adverse events or near adverse events that occur in Australia to the TGA within the following timeframes:

• 48 hours after becoming aware of an event that represents a serious threat to public health;
• 10 days after becoming aware of an event that leads to death, or a serious deterioration in the state of health, of a patient, device user or another person; or
• 30 days after becoming aware of an event, occurrence or recurrence that might lead to the death, or serious deterioration in the state of health, of a patient, a device user or another person.

Post-Market Review

The TGA may select a therapeutic good that is included on the ARTG for post-market review at any time. A therapeutic good may be selected for post-market review because the TGA has:

• detected a trend or signal amongst post-market data held by the TGA which necessitates a review of the therapeutic good;
• received information from other medical device regulators about the therapeutic good;
• identified a safety or performance issue in relation to a similar therapeutic good included on the ARTG;
• identified unresolved or repeated recalls of the therapeutic good; or
• reviewed the literature of available evidence and determined a review is required.

If a therapeutic good has been selected for post-market review, the TGA will write to the sponsor to request further information. The TGA may require the sponsor to implement corrective actions to mitigate any risks identified by the TGA associated with the therapeutic good, including amendments to the instructions for use, design changes, product recall, suspension or cancellation of the therapeutic good from the ARTG and the imposition of further conditions for the therapeutic good, such as reporting requirements or restrictions of use to particular patient cohorts or medical conditions.

Record-Keeping Requirements

Manufacturers are required to hold appropriate evidence to demonstrate the application of the appropriate conformity assessment procedures. Evidence of such conformity must be maintained and kept for a minimum of five years after the manufacture of the last medical device.

The sponsor must maintain records of the details of import, export and supply of medical devices. Records must be retained for ten (for Class 4 IVDs, Class III and Class IIa devices) or five (for all other classes of devices) years after distribution of the last medical device.

Corrective Actions

There are four types of correction actions that may be undertaken to resolve an issue with a therapeutic good that has already been supplied:

• Recall – this action is conducted when there are deficiencies or potential deficiencies in safety, quality, efficacy, performance or presentation. The action removes the goods from the market or use.
• Product defect correction – this action is conducted when there is a specific or potential deficiency that can be corrected. In some instances, the product can continue to be used if there is robust mitigation in place until a permanent correction has been implemented.
• Hazard alert – this action is available for implanted medical devices with a deficiency or potential deficiency relating to its safety, quality, performance or efficacy.
• Product defect alert – this action is available in relation to critical therapeutic goods for which there is no alternative product, or for which discontinuation of the good will result in interruption of patient treatment.

Product Recall

Both the TGA and ACCC have powers to mandate a product recall if they consider the product to be unsafe as a result of reports from external sources, including consumers, overseas regulators and healthcare professionals. The manufacturer or supplier must follow the guidance and direction of the TGA and/or ACCC in carrying out the product recall.

Under the TG Act, the sponsor has an obligation to initiate a recall in some circumstances – a distinction is made between “immediate” recalls and all other recalls or non-recall actions. An immediate recall is required when a sponsor becomes aware of a serious risk associated with a therapeutic good. In such circumstances, the sponsor must contact the Australian Recall Coordinator (ARC). If the risk relates to tampering, the ARC must be notified within 24 hours of becoming aware of the risk. For all other recalls, the sponsor must first conduct a risk analysis before notifying the TGA.

A supplier or manufacturer also has the option of undertaking a voluntary recall under the ACL if it has determined:

• a product will or may cause injury to any other person;
• there is a reasonably foreseeable use (including a misuse) of the consumer goods that will or may cause injury to any other person;
• a safety standard for the consumer goods is in force and the goods do not, or it is likely that they do not, comply with the standard; or
• an interim ban, or a permanent ban, on the consumer goods is in force.

The supplier/manufacturer has two days to notify the ACCC of the voluntary recall action.

The regulatory authorities relevant to the product categories in section 1. Applicable Product Safety Regulatory Regimes are:

• the Therapeutic Goods Administration (TGA); and
• the Australian Competition and Consumer Commission (ACCC).

TGA

The TGA has jurisdiction to enforce compliance with laws that regulate therapeutic goods in Australia. The TGA has a wide range of enforcement mechanisms to address non-compliance:

• warning letters;
• suspensions from the ARTG;
• cancellations from the ARTG;
• court enforceable undertakings;
• injunctions;
• advertising directions notices;
• infringement notices;
• civil penalties; and
• criminal prosecutions.

ACCC

The ACCC is responsible for enforcing compliance with the CCA and the ACL. The main enforcement mechanisms include:

• implementing a business compliance programme;
• court enforceable undertakings;
• infringement notices (fines); and
• bringing a claim in the Federal Court of Australia, including for injunctions and penalties.

Penalties Under the TG Act

A number of product safety offences exist in relation to therapeutic goods under the TG Act. For example, it is an offence to:

• supply a medical device that does not comply with the Essential Principles;
• supply a medical device that is not included on the ARTG;
• advertise a medical device as being for a purpose that is not listed in the ARTG, and using the medical device for the advertised purpose has resulted in and would at least likely result in harm or injury to any person; and
• fail to notify the TGA of any malfunction or deterioration in the characteristics or performance of the device that might lead to the death of a user of the device, or to a serious deterioration in their health.

The penalties for a contravention of the TG Act include up to 4,000 penalty units (equivalent to AUD1,252,000 as of July 2023) and/or imprisonment for up to five years.

Penalties Under the ACL

Product safety offences also exist under the ACL in relation to consumer goods. For example, it is an offence to:

• make a false or misleading representation about the product, including that the goods are of a particular standard or quality;
• supply goods that do not comply with applicable safety standards; or
• supply goods that are the subject of a recall notice.

The maximum penalty for a corporation is the higher of:

• AUD50,000,000; or
• if the court can determine the benefit obtained, three times that value; or
• if the court cannot determine the benefit, 30% of the corporation’s turnover during the relevant turnover period.

The maximum penalty for an individual is a fine of AUD2,500,000.

In June 2022, Philips was issued with two infringement notices (one for each entry in the ARTG) amounting to AUD133,200 for failing to provide information on the deterioration of the performance of these machines which would lead to a serious deterioration in the user’s health. This enforcement action followed original recall action in June 2021, along with a post-market review of these devices.

Product liability claims can be brought under the common law of contract and tort (negligence), as well as under statutory provisions such as those under the ACL.

Under Part 3-5 of the ACL, manufacturers are held strictly liable for supplying consumer goods with a safety defect. A product has a safety defect if it does not meet the expected level of safety. Affected consumers are entitled to seek compensation from a manufacturer who has supplied a product with a safety defect if that product has caused loss or damage. It is noted that some statutory defences apply, for example, if the safety defect did not exist at the time of supply by the manufacturer.

Under the ACL, manufacturers, importers and suppliers of consumer goods must comply with certain guarantees, including a guarantee that the goods are of acceptable quality. To be “of acceptable quality”, the goods must be safe and free from defects. Such guarantees cannot be excluded by contract. Affected consumers are entitled to seek damages against both the manufacturer and the supplier in respect of goods that fail to meet this guarantee under sections 259 and 271 of the ACL. The consumer may also be entitled to have the goods replaced, repaired or refunded.

The TGA has overseen several product safety alerts and consumer-level product defect corrections in relation to potential safety issues arising from defects in medical device software. In these instances, the TGA has not recommended a recall of the medical device and no legal action was brought against the manufacturer or supplier of the medical device. Accordingly, it is not clear yet how technological advancements in medical devices and consumer health products impact the application of product liability laws in Australia.

Generally, a claim may be brought against a defendant in an Australian court if either the defendant is located in Australia, or if the relevant conduct occurred in Australia. In the context of a product liability claim, it would likely suffice that the injury caused by the product occurred in Australia.

A claim may be brought under the ACL against any entity (even one that is based out of Australia) if it is “carrying on business within Australia”.

Only the TGA has standing to bring a claim in relation to a breach of the TG Act, TG Regulations and Medical Devices Regulations.

The general rule in relation to the recovery of costs in Australia is that costs follow the event unless it appears that some other order should be made. Thus, an award for costs will usually be levied on the unsuccessful party in the dispute and assessed on an ordinary basis, being a fair and reasonable amount for the legal costs and disbursements that were reasonably incurred in the conduct of the proceedings.

Indemnity costs, where all legal costs are recoverable, may be ordered where the party entitled has been wantonly or recklessly caused to incur costs.

Where an offer of compromise was made and unreasonably rejected and the result of litigation is no more favourable to the successful party than the offer of comprise, the successful party is entitled to an order for costs on an ordinary basis up to the date of the offer of compromise, but the unsuccessful party may be entitled to an order against the successful party for its costs on the indemnity basis thereafter.

There are no specific cost rules in relation to product liability claims, although some courts have specific rules regarding personal injury matters.

A decision by a public authority such as the Minister for Health or ACCC may be subject to both judicial review by a court and merits review by the Administrative Appeals Tribunal (AAT). For example, an affected person may apply to the AAT for a review of certain decisions made by the Minister for Health or Secretary under the therapeutic goods legislation, including decisions relating to the manufacturing of therapeutic goods, suspension and cancellation from the ARTG and conformity assessment certificates.

Legislation has been enacted at both the Commonwealth, and State and Territory levels to provide for the appointment of royal commissions and other public inquiries. Royal commissions are the highest form of inquiry on matters of public importance, with broad powers to summon witnesses and obtain evidence. Royal commissions often identify potential contraventions, thus triggering regulatory action and litigation.

The coroner can undertake an inquest into a death where there is reasonable cause to suspect that the person died of violent or unnatural death, a sudden death, the cause of which is unknown, or a medical practitioner has not provided a medical certificate in relation to the death, amongst other causes. Whilst a coroner cannot find a person guilty of an offence, they may make comments or recommendations on matters connected with the death, including matters related to public health, safety or the administration of justice.

In Australia, one or more person(s) is entitled to bring a class action on behalf of a group of at least seven people who have suffered the same or similar harm arising from the same or similar circumstances. The process, which is initiated by the filing of the claim, is often lengthy and challenging as it proceeds through the stages of discovery and evidence gathering, potential mediation, and eventually the trial. As a result, affected companies often choose to settle, regardless of the validity of the legal claim.

In March 2023, the Federal Court of Australia made orders approving the settlement sum of AUD300 million in the Johnson & Johnson pelvic mesh class action. This is the largest settlement in a product liability class action in Australia to date. The class action sought damages for women who allegedly suffered complications from the implantation of pelvic mesh devices manufactured by Ethicon and marketed and sold by Johnson & Johnson.

ADR processes, including mediation, are available as a means to resolve the dispute in question. In the early stages of a case, the judge will generally consider whether any ADR processes will assist, and in some cases, order that the parties attend mediation. Arbitration is also available as an alternative dispute resolution mechanism, and is often used in commercial contexts.

In general, it is likely that regulatory authorities such as the TGA and ACCC are already aware of potential defects and are conducting their own investigations and through public reporting channels. This is because the TGA and ACCC are active in monitoring defects. Further, manufacturers and suppliers are obligated to notify the relevant authority of any adverse events or serious circumstances, for example, when the defect might lead to death, serious deterioration of health or serious injury.

See 5.2 Legislative Reform.

The following regulatory changes can be expected in relation to medical devices as part of the TGA’s Action Plan:

• changes to the adverse event reporting processes;
• the establishment of a Unique Device Identification system for medical devices;
• subject to the findings of a consultation which closed on 28 July 2023, there may be a change in the regulation of medical devices containing materials of animal, microbial or recombinant origin; and
• subject to the results of surveys conducted in May 2023 targeting stakeholder groups involved in the manufacture of medical devices at the point of care, there may be refinement to the personalised medical devices framework.

AI has broadened the potential for how technology can be harnessed to inform or, in some cases, replace clinical decisions, or even directly provide therapy to an individual. In particular, there has been an interest in how AI text-based language models such as ChatGPT can be incorporated into products that have a medical purpose. There have been reports of some Australian doctors being prohibited from using ChatGPT to write medical notes over concerns of security risks and breaches of patient confidentiality.

AI is currently not specifically regulated in Australia. However, it can be expected that Australia will, in the future, follow jurisdictions such as the European Union and Canada in adopting AI-specific legislation. As of August 2023, the Australian Government is on track to complete an industry consultation on safe and responsible AI (see discussion paper here). With the paper referring to the capability of AI in supporting the diagnosis and early detection of health conditions, it is likely that any future AI-specific legislation would address the application of AI to medical devices and consumer health products.