Do medical devices and therapeutic goods need to comply with anti-dumping + countervailing duties?
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: Only if
Only if you import goods into Australia. Being in this industry makes the obligation worth checking (Industry: Medical devices & therapeutic goods), but the trigger is a fact the industry alone does not settle.
The obligation in brief
Comply with anti-dumping + countervailing duties. Part XVB of the Customs Act 1901 sets the procedure for anti-dumping and countervailing measures, and the duties themselves are imposed under the Customs Tariff (Anti-Dumping) Act 1975. The Australian Trade Remedies Commission (formerly the Anti-Dumping Commission, now also responsible for safeguard inquiries) investigates applications by Australian producers that dumped or subsidised imports are injuring an Australian industry, and the Minister decides whether to publish a dumping or countervailing duty notice (ss 269TG and 269TJ).
Trigger: Entering for home consumption goods of a kind, origin and exporter specified in a published dumping or countervailing duty notice, including goods brought within a notice after an anti-circumvention inquiry.
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 30 of those industries the answer for "Comply with anti-dumping + countervailing duties" is no. Medical devices & therapeutic goods is one of the 5 where the answer is different: only if.
The deciding fact for medical devices and therapeutic goods: Industry: Medical devices & therapeutic goods; applies only if you import goods into Australia.
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 a trigger outside this questionnaire).
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 | Check | Check | Check | Check | Check | Check |
| Partnership | Check | Check | Check | Check | Check | Check |
| Trust | Check | Check | Check | Check | Check | Check |
| Pty Ltd company | Check | Check | Check | Check | Check | Check |
| Public company | Check | Check | Check | Check | Check | Check |
| Not-for-profit (unregistered) | Check | Check | Check | Check | Check | Check |
| Registered charity | Check | Check | Check | Check | Check | Check |
| Super fund | Check | Check | Check | Check | Check | Check |
| Foreign company | Check | Check | Check | Check | Check | Check |
What the obligation requires
- When due
- Interim duty is payable at entry, with each import declaration. An importer that considers the interim duty exceeds the actual dumping margin or subsidy may apply for a duty assessment within six months after the end of the importation period (Customs Act s 269V).
- Evidence to keep
- Check of the dumping commodity register before each order; import declarations showing the dumping duty notice, exporter and interim duty; commercial invoices, export price and origin evidence; supplier correspondence relevant to circumvention risk; duty assessment applications with normal value and export price workings (s 269W).
- Maximum penalty
- A false or misleading statement in a declaration that results in duty being underpaid is a strict liability offence punishable by a fine of the greater of 60 penalty units ($21,840) or the duty shortfall (Customs Act 1901 s 243T)
- Regulator
- ABF
- Jurisdiction
- Commonwealth (national)
Other obligations where medical devices & therapeutic goods differ from the norm
- Comply with self-assessed clearance + Integrated Cargo System (ICS): Only if
- Conduct post-market surveillance of therapeutic goods: Yes
- In-vitro diagnostic medical device classification + ARTG: Yes
- Comply with the Therapeutic Goods Advertising Code: Yes
- Customs Act 1901 — import declarations + duties: Only if
- Notify ACCC of a voluntary recall within 2 days: Yes
- All 8 answers for medical devices & therapeutic goods
Questions
- Do medical devices and therapeutic goods need to comply with anti-dumping + countervailing duties?
- Only if you import goods into Australia. Being in this industry makes the obligation worth checking (Industry: Medical devices & therapeutic goods), but the trigger is a fact the industry alone does not settle.
- Is the answer the same for every industry?
- No. For 30 of the 35 industries Rules Mate maps, the answer is no. Medical devices & therapeutic goods is one of 5 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.