Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020

The Therapeutic Goods (Medical Devices,Excluded Purposes) Specification 2020 is a legislative instrument made under paragraph 41BEA of the Therapeutic Goods Act 1989. Its sole mechanical effect is to specify certain purposes as “excluded purposes” for three categories of in vitro diagnostic (IVD) medical devices that are intended for self-testing by a lay person. The categories are: Class 1 IVD medical devices for self-testing (section 4A), Class 2 IVD medical devices for self-testing (section 5), and Class 3 and Class 4 IVD medical devices for self-testing (section 6). For each category, the instrument lists one or more purposes in Schedule 1.

When a self-test IVD medical device is for one of those specified purposes, the Act provides that the device is not required to be included in the Australian Register of Therapeutic Goods (ARTG) under section 41FD(ia), or that the Secretary may determine that the device is not subject to specified provisions of the Act under section 41FF(1A). In short, the instrument carves out certain categories of self-test from the ordinary requirement to obtain ARTG inclusion before supply. The exclusion is not absolute: each section imposes conditions. For example, under section 4A, the device must not be intended exclusively for testing to monitor a diagnosed disease or condition, nor exclusively for export, nor exclusively for use in a government health screening program. Similar conditions apply for Class 3 and 4 devices under section 6, while Class 2 devices under section 5 have only the “not exclusively for export” and “not exclusively for government screening” conditions (no exclusion for monitoring a diagnosed condition).

The instrument was registered in 2020 and is closely tied to the COVID-19 pandemic. The schedules explicitly refer to testing for SARS-CoV-2 antigens or nucleic acid as an excluded purpose for both Class 1 and Class 3/4 devices, though with different scope. For Class 1 devices, the excluded purpose is “testing specimens from the human body in relation to a serious disease” subject to a list of exceptions; for Class 3/4 devices, the excluded purpose is simply “testing specimens from the human body” subject to the same list of exceptions. The practical effect is that self-test kits for many common infectious diseases and some chronic conditions (such as diabetes, kidney disease, and cardiovascular disease) are not excluded, meaning they remain subject to the full regulatory pathway under the Act. By contrast, self-test kits for conditions not on the exception list - including many rare diseases or novel pathogens - could fall within the excluded purpose and therefore be supplied without ARTG inclusion, provided the other conditions are met. This asymmetry is a deliberate design feature: the instrument raises the regulatory floor for high-risk self-tests that detect serious diseases, while lowering it for lower-risk or novel self-tests that the regulator wishes to encourage.

Excluded purpose is the central concept. It is not defined in the instrument itself, but is referenced back to the Act. Under sections 41FD(ia) and 41FF(1A), the Secretary may specify purposes that, if a device is for such a purpose, trigger an exemption from certain regulatory requirements - most importantly, the requirement that the device be included in the ARTG. The instrument fills in that specification. “Excluded purpose” therefore describes a use case for which supply of the device is either entirely exempt from the premarket approval process or subject to a streamlined process at the Secretary’s discretion.

IVD medical device for self-testing is a term used throughout but not separately defined in this instrument; it has the meaning given in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). Self-testing means the test is designed to be performed by a lay person outside a clinical setting, without professional supervision. The four device classes (Class 1, 2, 3, and 4) are also defined by reference to the Regulations. The classification system reflects increasing risk: Class 1 is lowest risk and Class 4 is highest risk. The instrument treats each class differently, reflecting the regulatory risk assessment.

Government health screening program is defined in section 4 as a health screening program that is conducted, approved, or funded by the Commonwealth or a State. This carve-out ensures that devices used exclusively in such programs are not eligible for the exclusion, because those programs are already subject to government oversight and may not need the regulatory flexibility.

Serious disease is defined by reference to the Regulations, and is used only in the context of Class 1 devices. Under Part 1A of Schedule 1, the excluded purpose for Class 1 self-test IVDs is “testing specimens from the human body in relation to a serious disease, other than to test for” a list of specific pathogens or diseases (chlamydia trachomatis, hepatitis B, hepatitis C, herpes simplex types 1 and 2, HIV types 1 and 2, seasonal influenza, neisseria gonorrhoea, treponema pallidum (syphilis), or the diagnosis of diabetes, kidney disease, or cardiovascular disease without genetic testing) or SARS-CoV-2. So for Class 1, the exclusion only applies if the test relates to a serious disease and is not for one of the listed exceptions.

SARS-CoV-2 is explicitly defined as the virus that causes COVID-19. It appears in the schedules for both Class 1 and Class 3/4 devices. Its inclusion signals that the instrument was drafted with the pandemic response in mind, allowing self-tests for COVID-19 to be supplied under a lighter regulatory regime.

The primary actors affected are sponsors (the Australian entity that arranges for the import or manufacture of the device with a view to supply) and manufacturers of self-test IVD medical devices. These entities are responsible for determining whether the device qualifies for the exclusion and for ensuring that the conditions in the instrument are met. If a device falls within an excluded purpose, they can supply it without first obtaining ARTG inclusion - a significant reduction in regulatory burden, cost, and time to market. If it does not, they must follow the full conformity assessment and inclusion pathway under the Act and Regulations.

Distributors and retailers are indirectly affected. If they source a self-test IVD that relies on the exclusion, they need to be satisfied that the sponsor has properly characterised the device. However, the legal obligation falls primarily on sponsors: section 41FD of the Act makes it an offence to supply a medical device that is not included in the Register unless an exemption applies. A distributor or retailer that supplies a device not included in the Register could face liability if the device does not in fact qualify for the exclusion.

Healthcare practitioners may be affected in their ability to recommend or prescribe self-tests. A practitioner who recommends a self-test that falls within an excluded purpose should be aware that the device has not undergone the same degree of premarket scrutiny as a fully included device. The exclusion does not necessarily mean the device is unsafe; it means the regulator has decided that the public health benefit of expedited access outweighs the risk, or that the risk is low enough to warrant lower regulatory oversight. Practitioners bear the clinical risk of relying on such devices.

Patients and consumers are the ultimate users. The instrument expands the range of self-tests available without prescription or professional administration. This increases consumer choice and convenience, but also shifts the burden of test selection, interpretation, and clinical follow-up to the individual. Consumers may not distinguish between a test that has been included in the ARTG and one that has been supplied under an exclusion.

State and Commonwealth health departments are affected because the instrument carves out government health screening programs from the exclusion. Devices used exclusively in such programs remain subject to the usual regulatory requirements, preserving the integrity of government-run screening initiatives.

The instrument does not impose new duties directly; it operates by modifying the application of duties under the Act. The key right it creates is the right for a sponsor or manufacturer to supply a self-test IVD medical device without first obtaining ARTG inclusion, provided the device is for an excluded purpose and meets the applicable conditions. That is a significant commercial right: it removes the requirement for a conformity assessment by the TGA and the associated fees, timelines, and administrative burden.

However, that right is conditional. Under section 4A, a Class 1 self-test IVD can only rely on the exclusion if: (a) it is for the purpose specified in Part 1A of Schedule 1; (b) it is not intended exclusively for testing to monitor a disease or condition that has been diagnosed by a suitably qualified health professional; (c) it is not intended exclusively for export; and (d) it is not intended exclusively for use in a government health screening program. Under section 5, Class 2 self-test IVDs have a similar but narrower set of conditions: (a) the device is for the purpose in Part 1 of Schedule 1 (faecal occult blood testing); (b) it is not exclusively for export; and (c) it is not exclusively for government screening. Note there is no condition about monitoring a diagnosed disease. Under section 6, Class 3 and 4 self-test IVDs have the same conditions as Class 1: not exclusively for monitoring a diagnosed disease, not exclusively for export, and not exclusively for government screening.

The duties that remain in force even for excluded devices are largely found in the Act. For example, the device must still comply with the essential principles for safety and performance (Part 4 of the Act), the sponsor must still maintain records and report adverse events, and the device must comply with applicable labelling and information requirements. The exclusion from ARTG inclusion does not exempt the device from the general prohibition on supplying unsafe devices or from the obligation to ensure the device is manufactured in accordance with quality management standards. The instrument does not mention these continuing duties, but the structure of the Act makes it clear that the exclusion is limited to the inclusion requirement; other provisions of the Act, such as the recall power, the power to impose conditions on supply, and the offence provisions for non-compliant devices, continue to apply.

Importantly, the instrument does not create a private right of action for consumers. It does not alter contractual rights or provide a defence in product liability litigation. A person harmed by a defective self-test IVD supplied under the exclusion can still sue under the Australian Consumer Law for breach of consumer guarantees or for negligence. The exclusion from premarket approval does not equate to an endorsement of safety or efficacy by the TGA.

The instrument itself does not prescribe any penalties. Penalties arise from the Therapeutic Goods Act 1989 and are triggered if a person supplies a medical device that is not included in the ARTG and no exemption applies. Section 41FD of the Act makes it an offence to intentionally or recklessly supply a device that is not included in the Register. The maximum criminal penalty for an individual is 5 years imprisonment and/or 5,000 penalty units; for a body corporate, it can be much higher (up to 50,000 penalty units, with each penalty unit currently $313, so approximately $15.65 million). Civil penalties also apply.

If a sponsor supplies a self-test IVD claiming it falls within an excluded purpose, but it does not meet the conditions (for example, the device is intended for monitoring a diagnosed disease, or the device is actually a Class 2 device but the sponsor incorrectly classifies it as Class 1), the exclusion does not apply, and the supply is unlawful. The burden is on the sponsor to correctly determine classification, conditions, and the purpose. There is no safe harbour for good faith errors.

Enforcement is by the TGA, which can conduct audits, inspections, and market surveillance. If the TGA finds a device being supplied in breach of the inclusion requirement, it can issue infringement notices, commence prosecution, or seek injunctions. The TGA can also issue a recall notice for devices that pose a serious risk, regardless of whether they were lawfully excluded.

The instrument’s schedules define what is excluded; any device not for a listed purpose (or for a listed purpose but failing a condition) is subject to the standard enforcement regime. For example, a Class 1 self-test for chlamydia trachomatis (which is on the exception list) cannot rely on the exclusion; if supplied without ARTG inclusion, it is in breach of section 41FD. Similarly, a Class 3 self-test for a disease not on the exception list, but which is intended exclusively for use in a government screening program, cannot use the exclusion because the condition in section 6(1)(e) is not met.

Practically, the instrument reduces enforcement risk for sponsors whose devices fall neatly into an excluded purpose and meet all conditions. But it increases the risk for those who misclassify or mis-characterise their device, because the consequences of error are the same as for a wholly unregistered device.

The instrument operates as a specification under the Therapeutic Goods Act 1989. Its legal effect is entirely dependent on the Act. It does not amend the Act or the Regulations; it only exercises a power to specify details. Therefore, it must be read together with the Act and the Therapeutic Goods (Medical Devices) Regulations 2002.

The Act contains other exemption provisions that may overlap. For instance, section 41FD(ia) deals specifically with excluded purposes; there is also section 41FD(ib) for devices for use in clinical trials, and section 41FD(ic) for devices supplied on the order of a medical practitioner. A device that is for an excluded purpose and also qualifies for another exemption may be able to rely on either. The instrument does not purport to be exclusive.

The interaction with government health screening programs is explicit: devices intended exclusively for such programs are carved out of sections 4A, 5, and 6. That means the exclusion does not apply, and the device must be included in the ARTG even if it otherwise would have been excluded. This is presumably to ensure the quality assurance of population screening programs.

The instrument also interacts with state and territory laws governing health services and pathology. Some states have laws that require certain tests to be performed only by accredited laboratories. Self-test IVDs are designed for lay use, so they may circumvent those laws. The instrument does not address this friction; a self-test IVD lawfully supplied under the exclusion could still contravene a state law requiring a medical prescription or laboratory involvement. Compliance with Commonwealth law does not automatically confer compliance with state law.

The Poisons Standard and scheduling of substances may also affect self-test IVDs. For example, a self-test that detects a scheduled medicine or involves a reagent that is itself a scheduled poison may face additional restrictions under state drugs and poisons legislation. The instrument does not touch on these; it only concerns the ARTG inclusion requirement.

The Australian Consumer Law applies fully. A self-test IVD supplied under the exclusion is still a “good” and must be of acceptable quality, fit for purpose, and match its description. The supplier can be liable for damages if the test is defective or unreliable, even if the TGA did not require premarket review. The instrument’s purpose is regulatory flexibility, not a limitation of consumer rights.

The source text provided is a consolidated version of the instrument as it stood at the time of retrieval. The instrument was made on an unspecified date in 2020, as indicated by its name. No amendment history is visible in the source. However, the presence of SARS-CoV-2 as an excluded purpose strongly suggests that the original instrument was introduced in response to the COVID-19 pandemic, possibly as part of a package of measures to facilitate the rapid supply of rapid antigen self-tests. It is plausible that earlier versions of the instrument did not include SARS-CoV-2, and that it was added later via amendment. But the source text does not confirm this.

The instrument is a legislative instrument subject to disallowance by Parliament. It may have been amended by later specifications or by an amending instrument registered on the Federal Register of Legislation. A thorough compliance check would require verifying the version history on the Federal Register. The instrument as reproduced here is the current version, as indicated by the inclusion of section 4A and Part 1A of Schedule 1 (for Class 1 devices). That part may have been inserted by an amendment, given that sections 5 and 6 refer to “Part 1” and “Part 2” respectively. The numbering “Part 1A” suggests it was added after the initial Parts 1 and 2.

No explanatory memorandum or statement of reasons is included in the source. Whether the instrument was subject to public consultation is unknown. Given the urgency of the COVID-19 response, it may have been made without the usual processes under the Legislation Act 2003. Practitioners relying on the instrument should confirm the version date and check for any amending instruments published after the version they hold.

The source text contains no references to litigation. There is no indication that the instrument has been challenged in court, nor that any court has interpreted its terms. Given its relatively narrow scope and the fact that it provides regulatory relief rather than imposing burdens, litigation is unlikely. However, two scenarios could give rise to litigation: (1) a competitor may argue that a sponsor is using the exclusion for a device that does not meet the conditions, thereby gaining an unfair competitive advantage; and (2) a consumer harmed by a defective excluded device may argue that the exclusion should not apply because the device was not for an excluded purpose, using that as part of a negligence claim.

The instrument may also be reviewed as part of broader judicial review of TGA decisions. If the Secretary makes a determination under section 41FF(1A) to revoke the exclusion for a particular device, that decision could be subject to challenge under the Administrative Decisions (Judicial Review) Act 1977.

To date, no published cases mention this specific instrument. That may change if the TGA revokes an exclusion for a high-profile device, or if a private litigant tests the boundaries of the instrument.

1. The “not intended exclusively” trap. The conditions in sections 4A(1)(c)-(e) and 6(1)(c)-(e) use the phrase “not intended exclusively”. This is narrower than “not intended”. A device can be intended for an excluded purpose and also for a non-excluded purpose. If the sponsor has mixed intentions, the condition is still satisfied as long as the device is not only for the carved-out use. For example, a Class 1 self-test for SARS-CoV-2 that is also intended for monitoring a diagnosed COVID-19 patient (i.e., not exclusively for that) would trigger the condition in section 4A(1)(c) and therefore be ineligible for the exclusion. Conversely, a device intended solely for the excluded purpose but also capable of being used for monitoring is not necessarily “intended exclusively” for monitoring if the sponsor does not market it for that purpose. The sponsor’s intended use, as reflected in labels, instructions, and promotional material, is key.

2. Class 2 devices: no monitoring exclusion. Under section 5, the conditions do not include the “not intended exclusively for testing to monitor a diagnosed disease” condition. So a Class 2 self-test IVD for faecal occult blood (the only excluded purpose for Class 2) can still rely on the exclusion even if it is used to monitor a diagnosed condition such as colorectal cancer. That is a notable asymmetry with Class 1 and Class 3/4.

3. Class 3 and 4 excluded purpose is extremely broad. Under Part 2 of Schedule 1, the excluded purpose for Class 3 and 4 self-test IVDs is “testing specimens from the human body, other than to test for” the specified list of pathogens/diseases or SARS-CoV-2. That means any self-test for any other condition (e.g., genetic predisposition to a non-listed disease, hormone levels, drug metabolites, biomarkers for non-listed cancers) falls within the excluded purpose. Because Class 3 and 4 are high-risk categories, this creates a curious situation: a very high-risk self-test (e.g., for a cancer rare but deadly) could be supplied without ARTG inclusion, while a lower-risk self-test for HIV or diabetes (which are on the exception list) cannot. The list of exceptions is fixed and cannot be added to except by amendment. This may result in regulatory gaps if new serious pathogens emerge that are not yet on the list.

4. Serious disease limitation for Class 1 only. For Class 1 devices, the excluded purpose is further limited to “testing specimens from the human body in relation to a serious disease”. So a Class 1 self-test for a non-serious condition (e.g., pH, pregnancy, fertility) is not covered by the excluded purpose, even if it is not for anything on the exception list. That means many common self-tests (pregnancy tests, ovulation tests) are not excluded and therefore require ARTG inclusion, even though they are low risk. This is a subtle but important boundary: the instrument is not a general exemption for all self-tests.

For a sponsor or manufacturer of a self-test IVD medical device who wishes to rely on this instrument to supply the device without ARTG inclusion, the compliance steps are as follows:

Step 1: Determine the device’s class. The classification is determined under Part 5.5 of the Therapeutic Goods (Medical Devices) Regulations 2002 and depends on risk factors such as whether the test detects a serious disease, the intended user, and the type of specimen. You must correctly assign the device to Class 1, 2, 3, or 4. If unsure, seek a TGA classification advice.

Step 2: Confirm the device is an IVD medical device for self-testing. That means the test is intended to be performed by a lay person without professional supervision. If the device is for professional use, the instrument does not apply.

Step 3: Identify the intended purposes. These are the purposes stated on the label, instructions, and promotional material. The instrument uses “intended” as the legal test. If the device has more than one intended purpose, you must check each purpose falls within an excluded purpose and that no purpose triggers the exclusion conditions.

Step 4: Check the applicable section and schedule.

• For Class 1: section 4A. The device must be for the purpose in Part 1A of Schedule 1 (testing for serious disease except the listed exceptions, plus SARS-CoV-2).
• For Class 2: section 5. The device must be for the purpose in Part 1 of Schedule 1 (testing for faecal occult blood).
• For Class 3 or 4: section 6. The device must be for the purpose in Part 2 of Schedule 1 (testing specimens from the human body except for the listed exceptions, plus SARS-CoV-2).

Step 5: Verify the conditions.

• For Class 1: ensure the device is not intended exclusively for monitoring a diagnosed disease, not exclusively for export, and not exclusively for use in a government health screening program.
• For Class 2: ensure not exclusively for export and not exclusively for government screening (no monitoring exclusion).
• For Class 3/4: same as Class 1.

Step 6: Document compliance. Maintain records showing the classification, intended purposes, and how each condition is satisfied. Retain evidence of the intended use analysis (e.g., marketing claims, labelling). The TGA may request this.