Medical devices & therapeutic goods compliance obligations in Australian Capital Territory: sole trader
Computed by the Rules Mate applicability engine for a sole trader with no employees, turnover $100K–$1M, in medical devices & therapeutic goods, operating in Australian Capital Territory and selling to consumers and small businesses.
Short answer: 17 obligations
17 obligations apply (6 critical) across 10 regulators, plus 6 to check. Risk rating: low. No licensed regime, no employees and not an APP entity — your obligations are mainly tax, consumer law and the general WHS duty.
Sole trader or company: what changes
Compared with the same business run through a Pty Ltd company with no employees in Australian Capital Territory, 0 obligations apply that did not, and 10 drop away.
- No longer applies: Apply for a Director Identification Number (Director ID)
- No longer applies: Comply with directors' general law and statutory duties
- No longer applies: Prevent insolvent trading (s 588G)
- No longer applies: Pay company PAYG/GST/SG or face Director Penalty Notice (DPN)
- No longer applies: Lodge the ASIC annual company statement and review fee
- No longer applies: Determine large proprietary company status annually
- No longer applies: Apply for a Tax File Number for new entities and partnerships
- No longer applies: Pay ASIC fees + lodge prescribed forms
What switches on when you take on staff
Moving to a sole trader with 1–5 employees, turnover $100K–$1M adds 20 obligations:
- Pay superannuation on every payday (Payday Super)
- Pay employees in accordance with the applicable modern award
- Manage psychosocial hazards at work
- Take reasonable and proportionate measures to prevent sex discrimination, sexual
- Withhold PAYG from employee and contractor payments
- Provide 10 days paid family + domestic violence leave (FDV)
- Document VEVO checks + retain employer records (s 245AYL Migration Act)
- Casual employment definition + conversion (Closing Loopholes 2024)
- Report under Single Touch Payroll Phase 2
- Honour employees' right to disconnect (s 333M)
Australian Capital Territory law that applies
2 Australian Capital Territory obligations apply on these facts:
| Obligation | Why it applies |
|---|---|
| PCBU primary duty of care (ACT WHS Act s 19) | Every business is a PCBU — the primary duty of care applies whether or not you employ anyone · ACT law |
| Industrial manslaughter offence (ACT WHS Act s 34A) | Applies to every PCBU and its officers — a death caused by reckless or negligent breach of a WHS duty is a crime · ACT law |
Payroll tax in Australian Capital Territory (FY2026-27)
ACT: 6.75% on Australian wages above the $1.75 million tax-free threshold (FY2026-27). On these facts the business is below the Australian Capital Territory threshold, so payroll tax does not apply yet.
- How the threshold works
- Flat tax-free threshold, apportioned by days employed and the ACT share of Australia-wide wages.
- Returns
- Monthly by the 7th of the following month; annual reconciliation by 28 July
- Administered by
- ACT Revenue Office
Australian Capital Territory regulators
Where the obligations sit
| Area | Obligations |
|---|---|
| Tax | 4 |
| Consumer law | 3 |
| Medicines | 2 |
| Whs | 2 |
| Privacy | 2 |
| Marketing | 2 |
| Records | 1 |
| Health | 1 |
Critical obligations on this profile
- Australian Business Number (ABN) application (Every business carrying on an enterprise needs an ABN)
- Lodge Business Activity Statements at assigned frequency (Turnover above the $75K GST registration threshold)
- Conduct post-market surveillance of therapeutic goods (Industry: Medical devices & therapeutic goods)
- In-vitro diagnostic medical device classification + ARTG (Industry: Medical devices & therapeutic goods)
Check whether these apply
- Wash outbound marketing lists against the Do Not Call Register: only if you make outbound telemarketing calls
- Comply with self-assessed clearance + Integrated Cargo System (ICS): only if you import goods into Australia
- Comply with anti-dumping + countervailing duties: only if you import goods into Australia
- Influencer + ad disclosure under ACL + AANA Code: only if you advertise to consumers or engage influencers
- Customs Act 1901 — import declarations + duties: only if you import goods into Australia
- Comply with AANA Code of Ethics + community guidelines: only if you advertise to consumers or engage influencers
Thresholds to watch
- Lose the Privacy Act small-business exemption at $3M annual turnover (removal of the exemption altogether is proposed, not yet law) (threshold $3M; approaching)
Questions
- How many compliance obligations apply to medical devices and therapeutic goods in Australian Capital Territory run as a sole trader with no employees?
- 17 obligations apply (6 critical) across 10 regulators, plus 6 to check. Risk rating: low. No licensed regime, no employees and not an APP entity — your obligations are mainly tax, consumer law and the general WHS duty.
- Which Australian Capital Territory laws apply?
- PCBU primary duty of care (ACT WHS Act s 19) and Industrial manslaughter offence (ACT WHS Act s 34A)
Related
- Medical devices & therapeutic goods compliance in Australian Capital Territory
- Medical devices & therapeutic goods: all obligations
- Compliance obligations by industry, state and size
- Medical devices & therapeutic goods in ACT: sole trader with employees
- Medical devices & therapeutic goods in ACT: partnership
- Medical devices & therapeutic goods in ACT: trading trust
- Medical devices & therapeutic goods in ACT: no employees
- Medical devices & therapeutic goods in ACT: 1–5 employees
- Medical devices & therapeutic goods in ACT: 20–99 employees
- Medical devices & therapeutic goods in ACT: 100–499 employees
- Medical devices & therapeutic goods in ACT: 20–99 employees, turnover $1M–$3M
- Medical devices & therapeutic goods in ACT: 6–19 employees, turnover $3M–$10M
- Medical devices & therapeutic goods in ACT: 100–499 employees, turnover $100M–$1B
- Medical devices & therapeutic goods in ACT: 500+ employees, turnover $1B+
- Medical devices & therapeutic goods in New South Wales: sole trader
- Medical devices & therapeutic goods in Victoria: sole trader
- Medical devices & therapeutic goods in Queensland: sole trader
- Medical devices & therapeutic goods in Western Australia: sole trader
- Medical devices & therapeutic goods in South Australia: sole trader
- Medical devices & therapeutic goods in Tasmania: sole trader
- Medical devices & therapeutic goods in Northern Territory: sole trader
- Conduct post-market surveillance of therapeutic goods: does it apply to medical devices & therapeutic goods?
- In-vitro diagnostic medical device classification + ARTG: does it apply to medical devices & therapeutic goods?
- Notify ACCC of a voluntary recall within 2 days: does it apply to medical devices & therapeutic goods?
- Comply with the Therapeutic Goods Advertising Code: does it apply to medical devices & therapeutic goods?
Sources
- ACT Revenue Office: payroll tax thresholds and rates
- PCBU primary duty of care (ACT WHS Act s 19)
- Industrial manslaughter offence (ACT WHS Act s 34A)
- Australian Business Number (ABN) application
- Lodge Business Activity Statements at assigned frequency
- Conduct post-market surveillance of therapeutic goods
- In-vitro diagnostic medical device classification + ARTG
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.