Medical Device Advertising Rules Australia 2025

1. Overview — Regulatory Framework

Medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA), a division of the Department of Health. The TGA's authority derives from the Therapeutic Goods Act 1989 (Cth) (TG Act) and the Therapeutic Goods (Medical Devices) Regulations 2002.

Advertising of medical devices is primarily governed by the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (TGA Advertising Code 2021), which replaced the 2018 Code and took full effect in January 2022.

Three Layers of Regulation

• TGA Advertising Code 2021 — governs content and format of all therapeutic goods advertising including medical devices
• Therapeutic Goods Act 1989 — sets criminal penalties for advertising ARTG-excluded devices, false/misleading claims, and supply offences
• Australian Consumer Law (ACL) — Schedule 2 of the Competition and Consumer Act 2010 — prohibits misleading conduct, false representations, and unconscionable conduct in trade or commerce

Unlike therapeutic drugs (which require TGA pre-approval for advertising via the Advertising Regulatory Framework), medical device advertisements are generally not pre-approved by the TGA. However, they must comply with all applicable codes at time of publication. This places the compliance burden squarely on the advertiser.

The ACCC jointly enforces ACL provisions with the TGA. Complaints may be lodged via the TGA complaint portal by consumers, competitors, or healthcare professionals.

2. TGA Device Classification & ARTG Requirements

The TGA classifies medical devices into four risk-based classes. Your device's classification determines its ARTG pathway and advertising obligations. You cannot lawfully advertise a device that must be ARTG-listed but is not.

ARTG Advertising Requirement

Under Section 41ML of the TG Act, it is an offence to advertise a medical device that is required to be, but is not, included in the ARTG. The maximum criminal penalty is 5 years imprisonment or 1,000 penalty units (~$330,000) for an individual, or 5,000 penalty units (~$1.65 million) for a corporation.

Key exemptions from ARTG listing (advertising rules still apply):

• Class I non-sterile, non-measuring devices (e.g. basic bandages, crutches)
• Devices exempt under the Therapeutic Goods (Exemptions from Part 4-11) Instrument 2018
• Custom-made devices meeting specific criteria
• Devices under TGA clinical trial approval

Always verify your device's current ARTG status via the TGA ARTG public search before publishing any advertising.

ARTG Entry vs Registration vs Listing

• Listed devices — Lower-risk; TGA relies on sponsor declaration of compliance; faster pathway
• Registered devices — Higher-risk (Class IIb/III); TGA conducts conformity assessment; takes longer and costs more
• In vitro diagnostic (IVD) devices — Classified separately under IVD-specific rules (Class 1–4 IVD scale); follow IVD advertising guidance

3. Therapeutic Claims — What You Can & Cannot Say

Under the TGA Advertising Code 2021, all therapeutic claims in medical device advertising must be:

• Accurate and not misleading
• Supported by sound clinical evidence
• Consistent with the device's approved intended purpose (ARTG entry)
• Not likely to create unwarranted fear or encourage inappropriate use

Off-Label Promotion — Highest Risk

Promoting a device for a use not included in its ARTG entry is off-label promotion and constitutes a serious breach of the TG Act. This includes:

• Promoting a device for conditions not in the ARTG entry
• Suggesting a device can diagnose a condition outside its approved indications
• Marketing a device for a patient population not covered by the ARTG listing
• Suggesting use without the need for professional supervision where required

Example Claims Analysis

4. Testimonials, Endorsements & Case Studies

Section 17 of the TGA Advertising Code 2021 prohibits the use of testimonials or endorsements that reference a person's experience with a therapeutic good, including medical devices.

This means an advertisement for a therapeutic good must not include:

• A statement by a consumer about their personal experience with the device's therapeutic effects
• An endorsement by any person (patient, celebrity, influencer) about the health benefits they received from the device
• Before-and-after presentations implying therapeutic outcome based on personal experience
• Star ratings or review excerpts that reference therapeutic outcomes in device advertising

What Is Still Permitted

The TGA Advertising Code 2021 does not prohibit all endorsements. The following may be permissible subject to careful framing:

• Healthcare professional endorsements — A clinician may describe the device's clinical utility in professional-facing content, provided they are qualified and the statement is substantiated
• General satisfaction statements — "I find this device easy to use" (no therapeutic outcome reference) — however, this is a grey area and should be reviewed by a regulatory lawyer
• Published clinical research — Citing peer-reviewed studies or clinical trial results is generally permitted
• Third-party review sites — Reviews on independent sites (Google, ProductReview) are not directly controlled by the advertiser, but re-sharing reviews in your own advertising likely constitutes "using a testimonial" under the Code

Influencer & Social Media Testimonials

Influencer marketing for medical devices is a high-risk area. Under the Code, if you pay, provide product, or otherwise compensate an influencer to discuss your device's therapeutic benefits, the influencer's content is considered your advertising material and is subject to the same rules.

5. Comparison Advertising Rules

The TGA Advertising Code 2021 permits comparative advertising but imposes strict requirements to prevent misleading or denigrating comparisons. The ACL also applies independently.

TGA Code Requirements for Comparisons

• Comparisons must be factual and not misleading
• The basis of comparison must be stated clearly and prominently
• Only equivalent product types may be compared (like-for-like)
• Comparisons must not denigrate a competitor's product in a way that cannot be substantiated
• Comparative performance claims must be supported by peer-reviewed clinical evidence or TGA-validated testing

ACL Requirements for Comparisons

Under the ACL, comparative advertising must not constitute:

• Misleading or deceptive conduct (s.18) — e.g. using outdated competitor data
• False representations (s.29) — e.g. falsely claiming your device is the "only TGA-approved" option in a category
• Misleading comparative advertising (s.53G) — specifically targeting head-to-head comparisons

6. Direct-to-Consumer vs Professional Advertising

The TGA Advertising Code 2021 distinguishes between advertising directed at healthcare professionals (HCPs) and advertising directed at consumers (the general public). Both must comply with the Code, but different provisions apply.

Consumer-Directed Advertising

Advertising directed at the general public for medical devices must:

• Not encourage self-diagnosis of serious conditions
• Not imply that professional consultation is unnecessary where it is required for safe use
• Include appropriate qualifications (e.g. "Always read the label. Follow the directions for use.")
• Not create unwarranted anxiety or fear
• Use language accessible to the general public, not misleading medical jargon

Healthcare Professional-Directed Advertising

Advertising directed exclusively at HCPs (e.g. trade publications, CME materials, professional conferences):

• May include more detailed technical and clinical information
• Must still not make unsubstantiated claims about efficacy or safety
• Must clearly distinguish between ARTG-approved indications and emerging evidence
• Must not include testimonials from patients about therapeutic outcomes
• May reference published studies in peer-reviewed journals

Prescription vs Non-Prescription Devices

Some medical devices are effectively "prescription-only" (e.g. must be supplied through a healthcare professional). For these devices, direct-to-consumer advertising must not:

• Encourage consumers to request the device from their GP without appropriate clinical assessment
• Imply the device is freely available over the counter when it requires a prescription or referral
• Undermine the role of the prescribing/recommending clinician

7. Social Media, Influencers & Digital Advertising

Social media is the highest-risk advertising channel for medical devices because content often blends personal experience with promotional intent, and because user-generated content can be rapidly reshared beyond the advertiser's control.

Key Principles for Digital & Social Advertising

• All TGA Code requirements apply equally to Instagram, Facebook, TikTok, YouTube, LinkedIn, email marketing, and paid digital ads
• Sponsored content must be labelled — ACCC influencer guidelines require clear disclosure of commercial relationships (#ad, #sponsored, #gifted)
• Comment sections and UGC — Sponsored content that generates user comments referencing therapeutic outcomes creates a grey-area risk; moderate actively or disable comments on therapeutic device posts
• Algorithm-targeted ads — Paid ads targeting users based on health conditions (e.g. targeting "people interested in back pain") do not create special TGA advertising exemptions; the same rules apply

Meta / Google Advertising Policies

In addition to TGA obligations, digital advertisers must comply with platform-specific health advertising policies:

• Meta (Facebook/Instagram) — Restricts advertising of "health-related products" including medical devices; many Class IIb/III device categories are restricted or prohibited from consumer advertising
• Google Ads — Medical devices require certification through Google's Healthcare and Medicines authorisation programme for certain device types and markets
• TikTok — Heavily restricts health product advertising; medical devices with therapeutic claims are largely prohibited from TikTok advertising

8. Penalties & TGA Enforcement

The TGA has broad enforcement powers under the TG Act. Non-compliance with advertising rules can result in criminal penalties, civil penalties, and reputational damage.

TGA Enforcement Actions

The TGA may take the following actions in response to advertising breaches:

• Compliance letter / request to withdraw — Most common first-step response; requires advertiser to remove non-compliant content
• Formal warning notice — Published on TGA website; significant reputational impact
• Infringement notice — Immediate financial penalty without prosecution
• Court-enforceable undertaking — Company agrees to compliance measures under court supervision
• Civil penalty proceedings — Pursued via Federal Court; can include multi-million dollar fines
• Criminal prosecution — Reserved for most serious offences; rare but possible
• ARTG suspension/cancellation — Device may be removed from ARTG, effectively banning Australian sales

9. Pre-Publication Compliance Checklist

Use this checklist before publishing any medical device advertisement in Australia:

• Device is ARTG-listed (if required for its class) — verify current ARTG number on TGA website
• All therapeutic claims are consistent with ARTG-approved intended purpose (no off-label promotion)
• All performance claims are supported by sound clinical evidence — citations available if requested
• No absolute or unqualified claims ("100% effective", "guaranteed", "cures all")
• No patient testimonials or consumer endorsements referencing therapeutic outcomes
• No before/after imagery that implies therapeutic outcome through personal experience
• Comparative claims are substantiated and do not denigrate competitors without evidence
• Consumer-directed ads do not encourage self-diagnosis of serious conditions
• Professional consultation recommended where device requires clinical oversight
• Influencer partnerships: disclosure of commercial relationship (#ad/#sponsored) included
• Influencer content does not reference personal therapeutic outcomes
• Digital ads comply with Meta/Google/TikTok healthcare advertising policies
• Mandatory qualifications included ("Always read the label. Follow the directions for use." where applicable)
• ARTG entry number included in advertising where the ad refers to ARTG registration
• Legal/regulatory review completed by TGA-experienced regulatory affairs specialist or healthcare lawyer