Medical devices & therapeutic goods compliance obligations in South Australia: 6–19 employees, turnover $3M–$10M
Computed by the Rules Mate applicability engine for a Pty Ltd company with 6–19 employees, turnover $3M–$10M, in medical devices & therapeutic goods, operating in South Australia and selling to consumers and small businesses.
Short answer: 53 obligations
53 obligations apply (19 critical) across 25 regulators, plus 14 to check. Risk rating: medium. No licensed regime, but you employ staff (WHS, Fair Work, super and payroll duties); you are an APP entity under the Privacy Act; 19 critical obligations apply.
Turnover $3M–$10M instead of $1M–$3M: what changes
Compared with a Pty Ltd company with 6–19 employees, turnover $1M–$3M in South Australia, 8 obligations apply that did not, and 1 drops away.
- Applies: Notifiable Data Breach (NDB) scheme
- Applies: Publish a Privacy Policy that meets APP 1
- Applies: Provide an APP 5 collection notice at or before collection
- Applies: APP 12 & APP 13 access and correction requests
- Applies: APP 7 direct marketing: consent, opt-out & when you can't message (2026)
- Applies: Privacy Act Reform — information controllers regime (proposed Tranche 2)
- Applies: Report ransomware and cyber extortion payments within 72 hours
- Applies: APP 2 — anonymity + pseudonymity for individuals
South Australia law that applies
2 South Australia obligations apply on these facts, and 1 more is worth checking:
| Obligation | Why it applies |
|---|---|
| PCBU primary duty of care (SA WHS Act s 19) | Every business is a PCBU — the primary duty of care applies whether or not you employ anyone · SA law |
| Industrial manslaughter offence (SA WHS Act s 30A) | Applies to every PCBU and its officers — a death caused by reckless or negligent breach of a WHS duty is a crime · SA law |
| Pay South Australian payroll tax when threshold met | Check: applies only if your annual Australian wages (grouped) exceed $1.5M |
Payroll tax in South Australia (FY2026-27)
SA: 4.95% on Australian wages above the $1.5 million tax-free threshold (FY2026-27). On these facts it may apply: 6–19 employees in SA — enter annual payroll to confirm; it applies only if your annual Australian wages (grouped) exceed $1.5M.
- How the threshold works
- Register once Australian wages exceed $1.5M; maximum deduction $600,000 a year ($50,000 a month).
- Returns
- Monthly by the 7th of the following month; annual reconciliation by 21 July
- Administered by
- RevenueSA
South Australia regulators
Where the obligations sit
| Area | Obligations |
|---|---|
| Privacy | 8 |
| Tax | 7 |
| Workplace | 7 |
| Directors | 4 |
| Whs | 4 |
| Consumer law | 3 |
| Super | 2 |
| Medicines | 2 |
| Migration | 2 |
| Corporations | 2 |
Critical obligations on this profile
- Notifiable Data Breach (NDB) scheme (Annual turnover over $3M — an APP entity under the Privacy Act (s 6D))
- Apply for a Director Identification Number (Director ID) (Incorporated company (Corporations Act))
- Comply with directors' general law and statutory duties (Incorporated company (Corporations Act))
- Prevent insolvent trading (s 588G) (Incorporated company (Corporations Act))
- Pay superannuation on every payday (Payday Super) (You have employees (6–19))
- Pay employees in accordance with the applicable modern award (You have employees (6–19))
- Manage psychosocial hazards at work (You have employees (6–19))
- Take reasonable and proportionate measures to prevent sex discrimination, sexual (You have employees (6–19))
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
- Pay South Australian payroll tax when threshold met: only if your annual Australian wages (grouped) exceed $1.5M
- Register R&D activities for the R&D Tax Incentive: only if you claim the R&D Tax Incentive
- 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
- Pay redundancy under NES (s 119 FW Act): only if you have 15 or more employees (FW Act s 121 small business exemption)
Questions
- How many compliance obligations apply to medical devices and therapeutic goods in South Australia with 6–19 employees, turnover $3M–$10M?
- 53 obligations apply (19 critical) across 25 regulators, plus 14 to check. Risk rating: medium. No licensed regime, but you employ staff (WHS, Fair Work, super and payroll duties); you are an APP entity under the Privacy Act; 19 critical obligations apply.
- Which South Australia laws apply?
- PCBU primary duty of care (SA WHS Act s 19) and Industrial manslaughter offence (SA WHS Act s 30A)
Related
- Medical devices & therapeutic goods compliance in South Australia
- Medical devices & therapeutic goods: all obligations
- Compliance obligations by industry, state and size
- Medical devices & therapeutic goods in SA: sole trader
- Medical devices & therapeutic goods in SA: sole trader with employees
- Medical devices & therapeutic goods in SA: partnership
- Medical devices & therapeutic goods in SA: trading trust
- Medical devices & therapeutic goods in SA: no employees
- Medical devices & therapeutic goods in SA: 1–5 employees
- Medical devices & therapeutic goods in SA: 20–99 employees
- Medical devices & therapeutic goods in SA: 100–499 employees
- Medical devices & therapeutic goods in SA: 20–99 employees, turnover $1M–$3M
- Medical devices & therapeutic goods in SA: 100–499 employees, turnover $100M–$1B
- Medical devices & therapeutic goods in SA: 500+ employees, turnover $1B+
- Medical devices & therapeutic goods in New South Wales: 6–19 employees, turnover $3M–$10M
- Medical devices & therapeutic goods in Victoria: 6–19 employees, turnover $3M–$10M
- Medical devices & therapeutic goods in Queensland: 6–19 employees, turnover $3M–$10M
- Medical devices & therapeutic goods in Western Australia: 6–19 employees, turnover $3M–$10M
- Medical devices & therapeutic goods in Tasmania: 6–19 employees, turnover $3M–$10M
- Medical devices & therapeutic goods in Northern Territory: 6–19 employees, turnover $3M–$10M
- Medical devices & therapeutic goods in Australian Capital Territory: 6–19 employees, turnover $3M–$10M
- 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
- RevenueSA: payroll tax thresholds and rates
- PCBU primary duty of care (SA WHS Act s 19)
- Industrial manslaughter offence (SA WHS Act s 30A)
- Notifiable Data Breach (NDB) scheme
- Apply for a Director Identification Number (Director ID)
- Comply with directors' general law and statutory duties
- Prevent insolvent trading (s 588G)
- Pay superannuation on every payday (Payday Super)
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.