1

adhesive removers and non-medicated skin cleansers relating to colostomy and ileostomy

1A

anatomical models that are intended by the manufacturer to be used for educational or record-keeping purposes

2

antiperspirant preparations that derive their antiperspirant properties from inorganic salts of aluminium, zinc or zirconium only

2A

articles that are non-sterile personal protective equipment or safety apparel other than articles specified in item 1 of Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020

2B

cosmetic finishing components for orthoses and prostheses

2C

craniofacial prostheses that are:

(a)   spectacle-retained; or

(b)   adhesive-retained

3

dental bleaches and dental whiteners

3AA

dental impression trays

3A

detergents and soaps for laundering or general cleaning use, other than detergents and soaps that are disinfectants within the meaning of the Regulations

4

devices for measuring alcohol content in body fluids or exhaled air

5

disinfectant and sterilant gases

6

drinking water purification and treatment equipment

7

ear candles

7AA

ear moulds that are intended by the manufacturer to anchor hearing aids

7A

fluoridated reticulated drinking water

8

hair bleaches, hair dyes, hair-colorants and hair-perming preparations

9

household and personal aids, or furniture and utensils, for people with disabilities

10

incontinence pads, mattress overlays and mattress protectors

10A

medicament trays that are intended by the manufacturer to hold medicaments

11

menstrual pads other than tampons and menstrual cups

11A

mouthguards intended by the manufacturer to be used to protect teeth from external forces including, but not limited to, mouthguards used in contact sports

11B

ocular prostheses intended by the manufacturer to be used for cosmetic purposes

11C

physical impressions of anatomy, and models cast from such impressions

12

sanitation, environmental control and environmental detoxification equipment (including films and coatings), other than articles specified in item 3 of Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020

Note:        Sanitation, environmental control and environmental detoxification equipment does not include disinfectants within the meaning of the Regulations.

12A

spectacle frames

13

topical preparations applied to the nails to harden, or deter the biting of, nails

14

products intended for application to the lips, that contain sunscreen, and do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, in relation to which one of the following two paragraphs applies:

(a)     for a product imported into, or manufactured in, Australia before 1 August 2018, both:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 or AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 6.2 and 6.3 of AS/NZS 2604: 1998 or clauses 5 and 6 of AS/NSZ 2604:2012; or

(b)     for a product imported into, or manufactured in, Australia on or after 1 August 2018, all of the following:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 5 and 6 of AS/NSZ 2604:2012; and

(iii)      if the product’s label states a protection factor, the label meets the requirements of clauses 7.1 and 7.3 of AS/NZS 2604: 2012; and

(iv)     the product must meet the performance requirements for a broad-spectrum product set out in clause 6.3 of AS/NZS 2604: 2012 and Table 1 in clause 5.2 of AS/NZS 2604: 2012

14A

software that is:

(a)   intended by its manufacturer to be used by a consumer for the self-management of an existing disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect; and

(b)   not intended by its manufacturer to be used:

(i)      in clinical practice; or

(ii)     in relation to a serious disease or serious condition, ailment or defect; or

(iii)    for the purpose of diagnosis, treatment, or making a specific recommendation or decision about the treatment, of a disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect

14B

software, or a combination of software and non-invasive hardware, that is:

(a)   intended by its manufacturer to be used by a consumer to promote or facilitate general health or wellness by measuring or monitoring (through non-invasive means) a physical parameter, such as movement, sleep, heart rate, heart rhythm, temperature, blood pressure or oxygen saturation; and

(b)   not intended by its manufacturer to be used:

(i)      in clinical practice; or

(ii)     for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a serious disease or a serious condition, ailment or defect

14C

software that is:

(a)   intended by its manufacturer to be used by a consumer to improve general health or wellness by coaching, or encouraging behavioural change, in relation to personal or environmental factors, such as weight, exercise, sun exposure or dietary intake; and

(b)   not intended by its manufacturer to be used:

(i)      in clinical practice or to provide information to the consumer that would generally be accepted to require the interpretation of a health professional; or

(ii)     for the purpose of diagnosis, prognosis, or making a decision about the treatment, of a disease, condition, ailment or defect

14D

software that is:

(a)   intended by its manufacturer to be used as a patient reported outcome measures (PROMs) questionnaire or patient survey; and

(b)   not intended by its manufacturer to diagnose, screen for, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect

14E

software that is a digital mental health tool (including a cognitive behaviour therapy tool) based on established clinical practice guidelines that are referenced and displayed in the software in a manner that is reviewable by the user

14F

software that is:

(a)   intended by its manufacturer to enable communications, including the transmission of patient information, for the purposes of supporting the delivery of health services; and

(b)   not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect

14G

software that is:

(a)   intended by its manufacturer to be used for the administration or management of health processes or facilities (including financial records, claims, billing, appointments, operating theatre management, hospital bed management, schedules, business analytics, admissions, inventory and workflow); and

(b)   not intended by its manufacturer to be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect

14H

software that is intended by its manufacturer to be used for the sole purpose of storing or transmitting patient images

14I

software that is:

(a)   intended by its manufacturer to be used for the sole purpose of providing alerts to health professionals in relation to patient care; and

(b)   not intended by its manufacturer to:

(i)      replace the clinical judgement of a health professional; or

(ii)     diagnose, screen for, prevent, alleviate, treat, or make a decision about the treatment of, a disease, condition, ailment or defect

14J

software that is:

(a)   intended by its manufacturer to be used for clinical workflow management; and

(b)   not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect

14K

software that is middleware and is:

(a)   intended by its manufacturer to connect or interface applications to an underlying operating system or another application, including by communicating or transmitting information; and

(b)   not intended by its manufacturer to:

(i)      control medical devices; or

(ii)     perform analysis, computation or logic that relates to the intended purpose of a medical device; or

(iii)    be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect

14L

software that is a calculator and:

(a)   either:

(i)      uses relevant published clinical standards or authoritative sources to make calculations; or

(ii)     displays calculations and outputs in a manner that may be validated by the user; and

(b)   is not intended by its manufacturer to control the administration of a calculated dosage

14M

software, or a combination of software and hardware, that is an electronic health record (however named or described) and is:

(a)    intended by its manufacturer to be used in clinical practice by healthcare providers to collect, use, disclose and otherwise manage patient clinical data within or between healthcare facilities; and

(b)    not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect

14N

software that is data analytics and is:

(a)   intended by its manufacturer to be used for the collection and analysis of class, group or population data; and

(b)   not intended by its manufacturer to be used for the purpose of diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation, of a disease, condition, ailment or defect in relation to individuals

14O

software that is a laboratory information management system (however named or described) and is not intended by its manufacturer to:

(a)   manipulate information or data to change, or generate new, diagnostic outputs (other than automating simple calculations or generating report comments); or

(b)   prevent, monitor, predict, make a prognosis of, treat or alleviate a disease, condition, ailment or defect

15

tinted bases and foundations, such as liquids, pastes or powders, that contain sunscreen, and do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, in relation to which one of the following two paragraphs applies:

(a)     for a product imported into, or manufactured in, Australia before 1 August 2018, both:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 or AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 6.2 and 6.3 of AS/NZS 2604: 1998 or clauses 5 and 6 of AS/NSZ 2604:2012; or

(b)     for a product imported into, or manufactured in, Australia on or after 1 August 2018, all of the following:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 5 and 6 of AS/NSZ 2604:2012; and

(iii)      if the product’s label states a protection factor, the label meets the requirements of clauses 7.1 and 7.3 of AS/NZS 2604: 2012; and

(iv)     the product must meet the performance requirements for a broad-spectrum product set out in clause 6.3 of AS/NZS 2604: 2012 and Table 1 in clause 5.2 of AS/NZS 2604: 2012

16

vaping devices, other than the following:

(a)   vaping devices that are intended, by the person under whose name the device is or is to be supplied, to be used exclusively for the vaporisation and administration of a medicine, including vaporiser nicotine

Note 1:    Examples of vaping devices include e‑cigarettes, e‑cigars, e‑hookah pens, e‑pens, e‑pipes and vape pens.

Note 2:    Vaporiser nicotine is a medicine that contains nicotine in salt or base form and may also be described as nicotine vape liquid, nicotine e-liquid or simply e-liquid.

1

anti-acne skin care products, including spot treatments, cleansers, face scrubs and masks, that do not contain any substance included in Schedules 2, 3, 4 or 8 to Poisons Standard

when advertised or presented for supply as controlling or preventing acne only through cleansing, moisturising, exfoliating or drying the skin

2

antibacterial skin care products that do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard

when advertised or presented for supply as being active against bacteria and not advertised or presented for supply as being:

(a)     active against viruses, fungi or other microbial organisms (other than bacteria); or

(b)     for use in connection with disease, disorders or medical conditions; or

(c)     active against a named bacterium that is known to be associated with a disease, disorder or medical condition; or

(d)     for use in connection with piercing of the skin or mucous membrane, for cosmetic or any other purpose; or

(e)     for use in connection with any procedure associated with the risk of transmission of disease from contact with blood or other bodily fluids; or

(f)      for use before physical contact with a person who is accessing medical or health services, or who is undergoing any medical or health care procedure; or

(g)     for use in connection with a procedure involving venepuncture or delivery of an injection

3

anti-dandruff hair care products

when advertised or presented for supply as controlling or preventing dandruff only through cleansing, moisturising, exfoliating or drying the scalp

4

compressed gases

when used as a power source for medical devices

4A

goods in relation to which the following paragraphs apply:

(a)    the goods comprise, contain or are derived from, human cells or human tissues collected from a patient (the relevant patient) who is under the clinical care of a medical or dental practitioner (the relevant practitioner);

(b)    the relevant practitioner is registered in a State or internal Territory;

(c)    subject to paragraph (d), all steps in the manufacture of the goods are carried out by, or under the professional supervision of, the relevant practitioner in a hospital in a State or internal Territory (the relevant hospital);

(d)    if a step in the manufacture of the goods relating to the storage or testing of the goods is not carried out in the relevant hospital, it is carried out by a person under contract with the relevant hospital

when the goods are:

(a)   used for the relevant patient, who is a patient of the relevant hospital; and

(b)    not advertised directly to consumers

4B

goods that are fresh viable human haematopoietic progenitor cells

when used for direct donor-to-host transplantation for the purpose of haematopoietic reconstitution

4C

goods that are fresh viable human organs or parts of human organs

when used for direct donor-to-host transplantation

4D

goods that are human reproductive tissue

when used in assisted reproductive therapy

4E

goods that are:

(a) human eggs; or

(b) human sperm

when used in carrying out an activity as authorised or purportedly authorised by a mitochondrial donation licence under the Research Involving Human Embryos Act 2002

5

moisturising skin care products, that contain sunscreen, and do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, for dermal application, including anti-wrinkle, anti-ageing and skin whitening products, in relation to which one of the following two paragraphs applies:

(a)     for a product imported into, or manufactured in, Australia before 1 August 2018, both:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 or AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 6.2 and 6.3 of AS/NZS 2604: 1998 or clauses 5 and 6 of AS/NSZ 2604:2012; or

(b)     for a product imported into, or manufactured in, Australia on or after 1 August 2018, all of the following:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:2012; and

(ii)       the product meets the performance requirements for a broad-spectrum product set out in clause 6.3 of AS/NZS 2604:2012 and Table 1 in clause 5.2 of AS/NZS 2604:2012; and

(iii)      any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 5 and 6 of AS/NSZ 2604:2012; and

(iv)     if the product’s label states a protection factor, the label meets the requirements of clauses 7.1 and 7.3 of AS/NZS 2604: 2012

when the product:

(a)     is not advertised or presented for supply as having a sun protection factor of more than 15; and

(b)     is not advertised or presented for supply as being water-resistant;
and

(c)     if the product is not stable for at least 36 months – includes an expiry date on its label; and

(d)     has a pack size not larger than 300mL or 300g; and

(e)     except in the manner provided below, does not have any therapeutic claims made in relation to it, including claims about skin cancer; and

therapeutic claims made in relation to the product are limited to those in relation to premature ageing in connection with sun exposure, and are only made if the product meets the performance requirements for broad-spectrum product set out in:

(a)     clause 7.2 of AS/NZS 2604:1998; or

(b)     both clause 6.3 of AS/NZS 2604:2012 and Table 1 in clause 5.2 of AS/NZS 2604:2012

6

oral hygiene products for the care of the teeth and the mouth, including dentifrices, mouth washes and breath fresheners, that do not contain any substance included in Schedules 2, 3, 4 or 8 to Poisons Standard

when advertised or presented for supply, the following two paragraphs apply:

(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 aliments, such as gum or other oral disease or periodontal condition, are not claimed to result from use of the product

7

packs and kits containing medical devices for the prevention of blood borne and sexually transmissible diseases where each individual therapeutic good contained within the packs or kits is already included on the Register

when advertised or presented for supply as a part of a Government endorsed health promotion program, having been expressly authorised by that Government as part of that program

8

piped medical gas systems

when installed and used in compliance with AS 2896–2011

9

preparations containing a sunscreening substance, if the primary purpose of the preparation is neither protection from solar radiation nor another therapeutic purpose

when the preparation is not advertised or presented for supply with:

(a)     a statement of claimed sun protection factor; or

(b)     a description of a claimed sun protection factor; or

(c)     a reference to another therapeutic use in respect of the preparation

10

sunbathing skin care products, such as oils, creams, gels, tanning products without sun and after-sun care products, that contain sunscreen with a sun protection factor of at least 4 and not more than 15, and do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, in relation to which one of the following two paragraphs applies:

(a)     for a product imported into, or manufactured in, Australia before 1 August 2018, both:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 or AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 6.2 and 6.3 of AS/NZS 2604: 1998 or clauses 5 and 6 of AS/NSZ 2604:2012; or

(b)     for a product imported into, or manufactured in, Australia on or after 1 August 2018, all of the following:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:2012; and

(ii)       the product meets the performance requirements for a broad-spectrum product set out in clause 6.3 of AS/NZS 2604:2012 and Table 1 in clause 5.2 of AS/NZS 2604:2012; and

(iii)      any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 5 and 6 of AS/NSZ 2604:2012; and

(iv)     if the product’s label states a protection factor, the label meets the requirements of clauses 7.1 and 7.3 of AS/NZS 2604: 2012

when the product:

(a)     is not advertised or presented for supply as having a sun protection factor of more than 15; and

(b)     is not advertised or presented for supply as being water-resistant; and

(c)     if the product is not stable for at least 36 months – includes an expiry date on its label;

(d)     has a pack size not larger than 300mL or 300g; and

(e)     except in the manner provided below, does not have any therapeutic claims made in relation to it, including claims about skin cancer; and

therapeutic claims made in relation to the product are limited to those in relation to premature ageing in connection with sun exposure, and are only made if the product meets the performance requirements for broad-spectrum product set out in:

(a)     clause 7.2 of AS/NZS 2604:1998; or

(b)     both clause 6.3 of AS/NZS 2604:2012 and Table 1 in clause 5.2 of AS/NZS 2604:2012

11

therapeutic goods for retaining, cushioning or repairing dentures

when advertised or presented for supply to the ultimate consumer

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

    /sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

exp = expires/expired or ceases/ceased to have

reloc = relocated

    effect

renum = renumbered

F = Federal Register of Legislation

rep = repealed

gaz = gazette

rs = repealed and substituted

LA = Legislation Act 2003

s = section(s)/subsection(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

(md) = misdescribed amendment can be given

Sdiv = Subdivision(s)

    effect

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

    cannot be given effect

Sub‑Ch = Sub‑Chapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

    commenced or to be commenced

Therapeutic Goods (Excluded Goods) Determination 2018

27 Sep 2018

(F2018L01350)

1 Oct 2018

¾

Therapeutic Goods Amendment (Excluded Goods) Determination 2019

21 June 2019

(F2019L00853)

22 June 2019

—

Therapeutic Goods Amendment (Excluded Goods) Determination (No. 2) 2019

15 July 2019

(F2019L00985)

16 July 2019

¾

Therapeutic Goods Amendment (Excluded Goods) Determination (No. 1) 2020

23 Apr 2020

(F2020L00464)

24 Apr 2020

¾

Therapeutic Goods (Excluded Goods) Amendment (Software-based Products) Determination 2021

15 Jan 2021

(F2021L00047)

25 Feb 2021

¾

Therapeutic Goods (Excluded Goods) Amendment (Vaping Devices) Determination 2021

11 Feb 2021

(F2021L00112)

12 Feb 2021

¾

Therapeutic Goods (Excluded Goods) Amendment (Borderline Products—COVID-19) Determination 2021

30 Jul 2021

(F2021L01049)

31 Jul 2021

¾

Therapeutic Goods (Excluded Goods) Amendment (Personalised Medical Devices) Determination 2021

20 Aug 2021 (F2021L01161)

21 Aug 2021

¾

Mitochondrial Donation Law Reform (Maeve’s Law) Act 2022

5 Apr 2022 (C2022A00026)

Sch 1 (item 116); 1 Oct 2022 (s 2(1) item 2)

¾

s 2........................................

rep LA s 48D

s 3........................................

am F2019L00853

s 4........................................

am F2019L00853; F2021L00047; F2021L00112; F2021L01161

Schedule 1...........................

am F2019L00985; F2020L00464; F2021L00047; F2021L00112; F2021L01049; F2021L01161

Schedule 2...........................

am F2019L00853; am C2022A00026

Note.....................................

rep F2019L00853