Does Therapeutic Goods Advertising Code apply to medical devices and therapeutic goods?
A computed answer from the Rules Mate applicability engine, with the exact condition, the outcome for every structure and size, and the primary source.
Short answer: Yes
Yes. This obligation applies to medical devices and therapeutic goods whatever their structure or size. The deciding fact: Industry: Medical devices & therapeutic goods.
The obligation in brief
Therapeutic Goods Advertising Code. The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, made under s 42BAA of the Therapeutic Goods Act 1989, sets the standard every advertisement for therapeutic goods directed to the public must meet. Advertisements must promote safe and proper use, must not mislead or create unrealistic expectations of performance, must support informed health care choices and must not be inconsistent with current public health campaigns.
Trigger: Publishing or causing the publication of any statement, image or design intended to promote the use or supply of a medicine, medical device, biological or other therapeutic good to members of the public, including online posts, hashtags, paid partnerships and in-store material.
Why medical devices & therapeutic goods get a different answer
Rules Mate runs its applicability engine across 9 business structures and 6 size bands for each of the 35 industries it maps. For 32 of those industries the answer for "Therapeutic Goods Advertising Code" is no. Medical devices & therapeutic goods is one of the 3 where the answer is different: yes.
The deciding fact for medical devices and therapeutic goods: Industry: Medical devices & therapeutic goods.
About the industry: Suppliers of therapeutic goods listed on the ARTG.
Compare a professional services (general) business with 6–19 employees structured as a Pty Ltd company: the obligation does not apply (Requires industry: Medical devices & therapeutic goods).
Answer by business structure and size
Each cell is the engine's outcome for a business in medical devices & therapeutic goods with that structure and size, assuming it sells to consumers and small businesses and holds customer contact details. "Check" means the obligation turns on a fact the industry does not settle.
| Structure | No employees | 1–5 employees | 6–19 employees | 20–99 employees | 100–499 employees | 500+ employees |
|---|---|---|---|---|---|---|
| Sole trader | Yes | Yes | Yes | Yes | Yes | Yes |
| Partnership | Yes | Yes | Yes | Yes | Yes | Yes |
| Trust | Yes | Yes | Yes | Yes | Yes | Yes |
| Pty Ltd company | Yes | Yes | Yes | Yes | Yes | Yes |
| Public company | Yes | Yes | Yes | Yes | Yes | Yes |
| Not-for-profit (unregistered) | Yes | Yes | Yes | Yes | Yes | Yes |
| Registered charity | Yes | Yes | Yes | Yes | Yes | Yes |
| Super fund | Yes | Yes | Yes | Yes | Yes | Yes |
| Foreign company | Yes | Yes | Yes | Yes | Yes | Yes |
What the obligation requires
- When due
- Before each advertisement is published, and for as long as it remains in circulation; each day a non-conforming advertisement continues is a separate contravention.
- Evidence to keep
- Completed TGA advertising compliance checklist or equivalent pre-publication review for each advertisement; ARTG entry showing the approved indications; evidence substantiating every claim; mandatory statements in place; written briefs and approval records for influencers and testimonials; any s 42DF approval or s 42DK permission relied on for a restricted or prohibited representation.
- Maximum penalty
- Civil penalty for an advertisement that does not comply with the Code (Therapeutic Goods Act 1989 s 42DMA) or that contains an unapproved restricted or prohibited representation (s 42DLB): 5,000 penalty units ($1.82M) for an individual and 50,000 penalty units ($18.2M) for a body corporate, with each day of a continuing contravention a separate contravention. Criminal offences also apply (s 42DM).
- Regulator
- TGA
- Jurisdiction
- Commonwealth (national)
Other obligations where medical devices & therapeutic goods differ from the norm
- Conduct post-market surveillance of therapeutic goods: Yes
- In-vitro diagnostic medical device classification + ARTG: Yes
- Comply with anti-dumping + countervailing duties: Only if
- Comply with self-assessed clearance + Integrated Cargo System (ICS): Only if
- Comply with the Therapeutic Goods Advertising Code: Yes
- Customs Act 1901 — import declarations + duties: Only if
- All 8 answers for medical devices & therapeutic goods
Other industries with a non-default answer
Questions
- Does Therapeutic Goods Advertising Code apply to medical devices and therapeutic goods?
- Yes. This obligation applies to medical devices and therapeutic goods whatever their structure or size. The deciding fact: Industry: Medical devices & therapeutic goods.
- Is the answer the same for every industry?
- No. For 32 of the 35 industries Rules Mate maps, the answer is no. Medical devices & therapeutic goods is one of 3 industries with a different answer.
Related
Sources
Computed by the Rules Mate applicability engine from the published obligation corpus; facts last checked 3 October 2026. Rules Mate is not a law firm and this is general information, not legal advice. Confirm your position with the regulator source or a qualified adviser before acting.