Beauty salons and aesthetic clinics increasingly use sophisticated products and equipment, including LED systems, laser and IPL equipment, radiofrequency devices, body-contouring technologies, skin products and cosmetic treatment products.

This can create confusion about the role of Australia’s Therapeutic Goods Administration.

A common misconception is that all professional beauty equipment must be “TGA approved” or that every product used in an advanced beauty treatment must appear on the Australian Register of Therapeutic Goods.

That is not the case.

Whether the Therapeutic Goods Administration regulates a particular product depends on what the product is, its intended purpose, how it is represented and, in some cases, its ingredients and route of administration.

Understanding this distinction can help salon owners avoid both regulatory problems and misleading marketing claims.

What Is the TGA?

The Therapeutic Goods Administration, commonly known as the TGA, is part of the Australian Government Department of Health, Disability and Ageing.

It regulates therapeutic goods supplied in Australia.

Therapeutic goods can include:

• medicines
• medical devices
• biologicals
• certain disinfectants and sterilants
• other products that fall within the therapeutic goods framework.

The TGA also monitors therapeutic goods after they enter the Australian market and has powers relating to compliance, safety monitoring, recalls and advertising.

However, the TGA does not regulate every beauty product or every item of salon equipment.

That distinction is important.

What Is a Therapeutic Good?

A therapeutic good is broadly a product represented or intended for therapeutic use.

The regulatory assessment can depend on matters including:

• what the manufacturer says the product is intended to do
• its labelling
• its instructions for use
• advertising claims
• ingredients
• route of administration
• how the product works.

A product may look like an ordinary beauty product but still fall within therapeutic-goods regulation if it is presented for a therapeutic purpose.

Conversely, equipment used in a beauty salon is not automatically a medical device simply because it uses advanced technology.

What Is a Medical Device?

Under Australia’s medical-device framework, a product may be a medical device where it is intended to perform particular therapeutic purposes, such as diagnosing, preventing, monitoring, treating or alleviating disease or injury, or modifying anatomy or a physiological process.

One of the most important concepts is intended purpose.

The intended purpose of a device can be established through material such as:

• product labelling
• instructions for use
• advertising
• technical documentation.

This means that two physically similar pieces of equipment could potentially have different regulatory classifications if they are represented for different purposes.

Beauty businesses should therefore avoid assuming that a type of equipment is either always regulated or never regulated by the TGA.

Does Every Beauty Device Need to Be on the ARTG?

No.

The Australian Register of Therapeutic Goods, or ARTG, is the public register of therapeutic goods that can lawfully be supplied in Australia where ARTG inclusion is required.

Most medical devices must be included in the ARTG before they can legally be supplied in Australia unless an exemption, exclusion or other lawful pathway applies.

However, equipment that is not a therapeutic good or medical device generally does not require ARTG inclusion simply because it is used professionally in a beauty salon.

This is why statements such as:

“All professional beauty machines must be TGA approved”

are incorrect.

The first question should be:

Is this product actually regulated as a therapeutic good or medical device?

If the answer is yes, the next question is whether ARTG inclusion or another regulatory pathway is required.

Is “TGA Approved” the Correct Term?

Beauty businesses should use care with the phrase “TGA approved.”

Different therapeutic goods can have different regulatory pathways.

For many medical devices, the relevant concept is that the device is included in the Australian Register of Therapeutic Goods.

It is therefore more accurate to identify the actual regulatory status rather than use “TGA approved” as a blanket marketing expression.

For example, where appropriate, a supplier might accurately state that a particular medical device is included in the ARTG and provide the relevant ARTG entry.

Salon owners should ask suppliers for evidence supporting regulatory claims rather than relying on logos or marketing statements.

What About Laser and IPL Equipment?

Laser and intense pulsed light equipment illustrates why broad claims about TGA regulation can be misleading.

A laser or IPL system is not automatically a medical device simply because it uses laser or light technology.

Its status depends on matters including its intended purpose and how it is represented.

A device intended for a therapeutic purpose may fall within the medical-device framework.

Other equipment intended solely for cosmetic purposes may be treated differently.

Separate state and territory radiation legislation can also apply to laser and IPL equipment.

This means that TGA regulation and operator licensing are separate issues.

A device being included in the ARTG does not automatically mean that any beauty therapist may legally operate it.

Likewise, a state radiation licence does not itself establish the product’s TGA status.

Businesses should check both Commonwealth therapeutic-goods requirements and applicable state or territory requirements.

What About Radiofrequency, Cavitation and Body-Contouring Equipment?

The same principle applies to:

• radiofrequency equipment
• ultrasound or cavitation systems
• body-contouring technologies
• electromagnetic muscle-stimulation systems
• skin-tightening equipment
• other energy-based devices.

These devices should not automatically be described as medical devices.

Their regulatory status depends primarily on their intended purpose and the representations made about them.

For example, equipment promoted solely for a cosmetic purpose may potentially have a different regulatory status from equipment promoted for treating a disease, injury, medical condition or physiological dysfunction.

This makes product advertising especially important.

Claims can affect how a product is regulated.

Cosmetic Products Are Not Automatically TGA Regulated

Ordinary cosmetic products are generally not regulated by the TGA merely because they are used in a beauty salon.

Examples can include products intended only to:

• cleanse the skin
• moisturise
• perfume
• alter appearance
• improve cosmetic appearance without making therapeutic claims.

Cosmetic ingredients are generally regulated through the Australian Industrial Chemicals Introduction Scheme — AICIS.

Consumer product safety and labelling requirements may also fall within the responsibilities of other regulators, including the Australian Competition and Consumer Commission.

However, a product marketed as a cosmetic can potentially become a therapeutic good depending on factors such as:

• ingredients
• route of administration
• therapeutic claims.

For example, claiming that a product treats eczema, heals a medical condition or modifies a physiological process can potentially place it within therapeutic-goods regulation.

The wording used to promote a product therefore matters.

“Medical Grade Skincare” Does Not Automatically Mean TGA Regulated

The term “medical grade” is frequently used in the beauty and skincare industry.

However, salon owners should not assume that describing a product as “medical grade” creates a recognised regulatory category.

The actual regulatory status of a skincare product depends on the applicable legislation, ingredients, intended purpose and claims.

A supplier’s marketing terminology should never replace proper regulatory verification.

Teeth Whitening

Teeth-whitening products are another area where oversimplification should be avoided.

It is not accurate to assume that every product below a particular peroxide percentage is automatically outside TGA regulation.

The regulatory status of a product may depend on:

• its formulation
• ingredients
• intended purpose
• route of administration
• therapeutic claims
• whether another regulatory framework applies.

Separate consumer product and dental-treatment requirements may also apply.

Beauty businesses should therefore avoid using a peroxide percentage alone to determine whether the TGA regulates a product.

Cosmetic Injectables

Cosmetic injectable products require particular care.

Some injectable products used for cosmetic purposes are prescription-only medicines or otherwise regulated therapeutic goods.

The prescribing, supply and administration of those products can be governed by:

• Commonwealth therapeutic-goods legislation
• state or territory medicines and poisons legislation
• practitioner registration
• scope-of-practice requirements
• Ahpra and National Board standards and guidelines.

A product being included in the ARTG does not mean an unregistered or unauthorised person may administer it.

Product regulation and practitioner authority are separate issues.

The ARTG Is a Valuable Verification Tool

When a supplier claims that a therapeutic good or medical device is included in the ARTG, salon owners can verify the relevant entry using the Australian Register of Therapeutic Goods.

Useful information can include:

• product or device details
• sponsor
• ARTG entry
• intended purpose
• applicable regulatory information.

However, simply finding something that appears similar in the ARTG is not sufficient.

Businesses should ensure that the entry actually corresponds to the product being supplied.

If you are uncertain, ask the supplier for the exact ARTG entry and supporting documentation.

What Is an Australian Sponsor?

For regulated therapeutic goods, an Australian sponsor has specific responsibilities under therapeutic-goods legislation.

The sponsor is generally the person or organisation responsible for supplying the therapeutic good in Australia.

This is different from an ordinary retailer or equipment reseller.

Where a device requires ARTG inclusion, salon owners purchasing equipment should establish:

• who the Australian sponsor is
• the ARTG entry
• whether the particular device supplied is covered by that entry
• whether the intended purpose matches how the salon intends to use and advertise the device.

Importing Equipment Directly

Direct importing creates additional considerations.

Buying a machine from an overseas marketplace does not remove Australian regulatory requirements.

If the equipment is a medical device or another therapeutic good, importing or supplying it in Australia can potentially create regulatory responsibilities.

Businesses considering direct importing should therefore establish the regulatory status before purchasing or importing the equipment.

Questions should include:

• Is the equipment a medical device?
• Does it require ARTG inclusion?
• Who is the Australian sponsor?
• Is the product already lawfully supplied in Australia?
• Am I taking on responsibilities beyond simply being an end user?
• Are electrical, radiation or state licensing requirements also relevant?

Price alone should never determine whether equipment is suitable for professional use.

Advertising Therapeutic Goods

Advertising therapeutic goods to the Australian public is regulated.

The Therapeutic Goods Advertising Code establishes requirements for therapeutic-goods advertising.

Among other things, advertising must be:

• accurate
• balanced
• not misleading
• supported by appropriate evidence
• presented in a way that promotes safe use.

Beauty salons should therefore be careful when advertising treatments involving regulated therapeutic goods.

Examples of risky claims include:

• “100% safe”
• “guaranteed results”
• “permanent cure”
• “clinically proven” without adequate evidence
• “TGA approved” where that description is inaccurate
• claims beyond the intended purpose of a medical device.

Australian Consumer Law can also apply to advertising.

A claim could potentially raise issues under more than one regulatory framework.

Do Therapeutic-Goods Advertisements Need TGA Pre-Approval?

Beauty businesses should not rely on old advice stating that advertisements generally need to be “pre-approved by the TGA.”

Instead, advertisers are responsible for ensuring that their advertising complies with the applicable therapeutic-goods advertising requirements.

Businesses should assess the actual rules applying to the therapeutic good and advertisement before publication.

Where there is uncertainty, professional regulatory advice may be appropriate.

Prescription-Only Medicines

There are particularly strict restrictions surrounding advertising prescription-only medicines to the public.

Beauty and cosmetic clinics offering services involving prescription medicines should carefully review TGA and Ahpra advertising requirements.

Using abbreviations, brand substitutes or euphemisms does not necessarily remove advertising obligations.

Clinics should not assume that because competitors advertise a treatment in a particular way, that advertising is compliant.

What About Before-and-After Photographs?

Before-and-after photographs may also constitute advertising.

Where a therapeutic good is involved, the images and surrounding claims need to comply with applicable advertising requirements.

Australian Consumer Law also prohibits misleading or deceptive representations.

Images should not exaggerate likely results through:

• substantially different lighting
• different angles
• expression changes
• filters
• retouching
• misleading cropping
• other presentation techniques that materially distort results.

Additional requirements can apply where a registered health practitioner or regulated health service is being advertised.

Buying Equipment from a Supplier

Before buying advanced beauty equipment, salon owners should perform reasonable due diligence.

Consider requesting:

• full manufacturer details
• supplier details
• intended purpose
• instructions for use
• relevant technical documentation
• ARTG details where the device requires ARTG inclusion
• Australian sponsor information where relevant
• warranty information
• servicing arrangements
• electrical safety documentation
• training information
• applicable radiation documentation
• evidence supporting marketing claims.

A supplier saying that equipment is “certified,” “medical grade” or “TGA approved” should not be accepted without verification.

Ask what the claim actually means and request the supporting evidence.

CE, FDA and Overseas Certifications

Overseas certifications or authorisations do not automatically establish that a product may lawfully be supplied in Australia.

For example, CE marking or US FDA status may be relevant documentation, but Australian regulatory requirements still need to be satisfied where they apply.

Australian businesses should verify the product’s Australian regulatory status rather than relying solely on overseas regulatory claims.

Product Recalls

Beauty businesses should have procedures for responding to safety alerts and recalls.

If a product or medical device used in the business becomes subject to corrective action or recall, the salon may need to:

• stop using the affected product
• identify affected stock
• record serial, batch or lot numbers
• contact the supplier
• follow recall instructions
• contact affected clients where necessary
• document actions taken.

Maintaining good purchasing and inventory records makes this process significantly easier.

Adverse Events

Problems involving therapeutic goods and medical devices can be reported to the TGA.

Examples of medical-device incidents can include:

• device malfunction
• unexpected injury
• burns
• electrical problems
• device failure
• an incident that could have caused serious harm.

Sponsors and manufacturers have particular reporting obligations.

Healthcare facilities, practitioners and consumers can also report safety problems.

A salon should have an internal incident-management process even when an event does not ultimately require a formal TGA report.

Record Keeping

Useful records for advanced treatments and regulated equipment can include:

• product name
• model
• serial number
• supplier
• purchase date
• Australian sponsor where relevant
• ARTG information where applicable
• instructions for use
• servicing and maintenance records
• staff training
• treatment settings
• batch and lot numbers for relevant products
• adverse-event reports
• recall information.

The appropriate records depend on the product and treatment.

ARTG Inclusion Does Not Mean a Treatment Is Automatically Legal

This is one of the most important concepts for beauty salon owners.

A device being lawfully supplied in Australia does not automatically mean:

• every beauty therapist may use it
• every treatment performed with it is permitted
• no state licence is required
• no training is required
• insurance automatically covers it.

Separate laws can regulate:

• practitioners
• medicines
• skin penetration
• radiation
• workplace safety
• local premises
• advertising.

TGA compliance is therefore only one component of salon compliance.

Training Does Not Replace Regulatory Compliance

Training is important, particularly when salons introduce advanced treatment technologies.

However, a training certificate does not change the legal classification of a product or device.

Likewise, course accreditation does not establish that a medical device is included in the ARTG or that an operator has any licence required by state legislation.

Businesses should treat:

training, equipment regulation, practitioner authority, insurance and premises compliance as separate questions.

A Simple TGA Compliance Check for Beauty Businesses

Before purchasing or using a new product or device, ask:

1. What is the product intended to do?
2. Is it simply a cosmetic product or cosmetic device, or is it potentially a therapeutic good?
3. What claims does the manufacturer make?
4. If it is a medical device, does it require inclusion in the ARTG?
5. If ARTG inclusion is claimed, what is the exact ARTG entry?
6. Who is the Australian sponsor?
7. Does the intended purpose on the regulatory documentation match how I intend to use it?
8. Are there separate state or territory licensing requirements?
9. Does my insurer cover the treatment and equipment?
10. Have staff received appropriate equipment-specific training?
11. Are our advertising claims consistent with the actual regulatory status and intended purpose?
12. Do we have procedures for maintenance, incidents and recalls?

Common TGA Compliance Mistakes

Beauty businesses should avoid these common assumptions:

“It has CE certification, so it is approved in Australia.”
Australian requirements must still be considered.

“The supplier says it is TGA approved.”
Ask for the actual regulatory evidence.

“All beauty machines need ARTG registration.”
Only products falling within the relevant therapeutic-goods framework require the applicable regulatory pathway.

“If it is on the ARTG, anyone can use it.”
Operator and treatment requirements are separate.

“It is only a cosmetic treatment, so therapeutic claims don’t matter.”
Advertising and intended-purpose claims can affect regulatory classification.

“A training certificate proves the device is legal.”
Training and product regulation are different matters.

Where Beauty Businesses Should Check

For current regulatory information, businesses should use primary sources wherever possible.

Useful authorities include:

• Therapeutic Goods Administration
• Australian Register of Therapeutic Goods
• Australian Industrial Chemicals Introduction Scheme
• Australian Competition and Consumer Commission
• relevant state or territory health department
• relevant state or territory radiation regulator
• local council
• professional indemnity and public liability insurer.

Do not rely exclusively on claims made by manufacturers, distributors, training providers or social media.

Final Takeaway

The TGA plays an important role in regulating therapeutic goods used in Australia’s beauty and aesthetic industries, but not every salon product or beauty device is a therapeutic good.

The correct approach is not to ask:

“Is beauty equipment TGA approved?”

Instead ask:

“What is the intended purpose of this particular product, how is it regulated in Australia, and what evidence supports that status?”

That distinction helps salons make better purchasing decisions, avoid misleading advertising and understand where TGA regulation fits within their wider compliance responsibilities.

Important Disclaimer

This article provides general educational information for Australian beauty businesses. It does not constitute legal or regulatory advice.

Regulatory status depends on the individual product, its intended purpose, claims, ingredients and applicable legislation. Businesses should confirm the current status of specific products with the Therapeutic Goods Administration, the Australian sponsor where applicable and other relevant regulators before relying on regulatory claims.