Medical devices & therapeutic goods compliance obligations for a sole trader
Computed by the Rules Mate applicability engine for a sole trader in medical devices & therapeutic goods with 1–5 employees, turnover $100K–$1M, selling to consumers and small businesses.
Short answer: 34 obligations
34 Commonwealth obligations apply to a sole trader in medical devices & therapeutic goods with 1–5 employees, turnover $100K–$1M (12 critical), plus 11 to check. Risk rating: medium. No licensed regime, but you employ staff (WHS, Fair Work, super and payroll duties); 12 critical obligations apply.
What the structure changes
Compared with a Pty Ltd company of the same size in medical devices & therapeutic goods, a sole trader picks up 0 Commonwealth obligations and drops 10.
- Does not apply: Apply for a Director Identification Number (Director ID)
- Does not apply: Comply with directors' general law and statutory duties
- Does not apply: Prevent insolvent trading (s 588G)
- Does not apply: Pay company PAYG/GST/SG or face Director Penalty Notice (DPN)
- Does not apply: Lodge the ASIC annual company statement and review fee
- Does not apply: Determine large proprietary company status annually
- Does not apply: Apply for a Tax File Number for new entities and partnerships
- Does not apply: Pay ASIC fees + lodge prescribed forms
- Does not apply: Discharge of directors' duties — practical evidence
- Does not apply: Beneficial ownership transparency (Tranche 3 — under consultation)
Critical Commonwealth obligations on this profile
- Pay superannuation on every payday (Payday Super) (You have employees (1–5))
- Pay employees in accordance with the applicable modern award (You have employees (1–5))
- Manage psychosocial hazards at work (You have employees (1–5))
- Take reasonable and proportionate measures to prevent sex discrimination, sexual (You have employees (1–5))
- 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)
- Withhold PAYG from employee and contractor payments (You have employees (1–5))
- Provide 10 days paid family + domestic violence leave (FDV) (You have employees (1–5))
Check whether these apply
- Lodge an FBT return and pay FBT by 21 May: only if you provide fringe benefits (cars, entertainment, loans) to employees
- 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
- Track eligibility for the electric car FBT exemption: only if you provide electric vehicles to employees
- Comply with AANA Code of Ethics + community guidelines: only if you advertise to consumers or engage influencers
State and territory law
This page counts Commonwealth obligations only. Payroll tax, workplace safety, licensing and other state duties depend on where the business operates; the industry's state pages list them.
Other structures and industries
Questions
- What compliance obligations apply to a sole trader in medical devices & therapeutic goods?
- 34 Commonwealth obligations apply to a sole trader in medical devices & therapeutic goods with 1–5 employees, turnover $100K–$1M (12 critical), plus 11 to check. Risk rating: medium. No licensed regime, but you employ staff (WHS, Fair Work, super and payroll duties); 12 critical obligations apply.
- What changes compared with a Pty Ltd company of the same size?
- A sole trader picks up 0 obligations and drops 10.
Related
- Medical devices & therapeutic goods: all obligations
- Compliance obligations by structure
- Compliance obligations by industry, state and size
- 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
- 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 harassment and victimisation (positive duty)
- Australian Business Number (ABN) application
- Lodge Business Activity Statements at assigned frequency
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.