Medical devices & therapeutic goods compliance obligations in Western Australia: 20–99 employees
Computed by the Rules Mate applicability engine for a Pty Ltd company with 20–99 employees, turnover $3M–$10M, in medical devices & therapeutic goods, operating in Western Australia and selling to consumers and small businesses.
Short answer: 53 obligations
53 obligations apply (18 critical) across 25 regulators, plus 13 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; 18 critical obligations apply.
What changes at 20–99 employees
Compared with a medical devices & therapeutic goods business with 6–19 employees in Western Australia, 9 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: Pay redundancy under NES (s 119 FW Act)
- 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
What switches on at 100–499 employees
Moving to a Pty Ltd company with 100–499 employees, turnover $10M–$100M adds 3 obligations:
Western Australia law that applies
1 Western Australia obligation applies on these facts, and 1 more is worth checking:
| Obligation | Why it applies |
|---|---|
| PCBU primary duty of care (WA WHS Act 2020 s 19) | Every business is a PCBU — the primary duty of care applies whether or not you employ anyone · WA law |
| Pay Western Australian payroll tax when threshold met | Check: applies only if your annual Australian wages (grouped) exceed $1M |
Payroll tax in Western Australia (FY2026-27)
WA: 5.5% on Australian wages above the $1 million tax-free threshold (FY2026-27). On these facts it may apply: 20–99 employees in WA — enter annual payroll to confirm; it applies only if your annual Australian wages (grouped) exceed $1M.
- How the threshold works
- Diminishing threshold: reduces by $2 for every $13 of Australian wages above $1M, reaching nil at $7.5M.
- Returns
- Monthly by the 7th of the following month; annual reconciliation by 21 July
- Administered by
- RevenueWA
Western Australia regulators
Where the obligations sit
| Area | Obligations |
|---|---|
| Privacy | 8 |
| Workplace | 8 |
| Tax | 7 |
| Directors | 4 |
| Whs | 3 |
| 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 (20–99))
- Pay employees in accordance with the applicable modern award (You have employees (20–99))
- Manage psychosocial hazards at work (You have employees (20–99))
- Take reasonable and proportionate measures to prevent sex discrimination, sexual (You have employees (20–99))
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 Western Australian payroll tax when threshold met: only if your annual Australian wages (grouped) exceed $1M
- 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
- Customs Act 1901 — import declarations + duties: only if you import goods into Australia
Thresholds to watch
- WGEA gender pay gap reporting becomes mandatory (threshold 100 employees; very close)
Questions
- How many compliance obligations apply to medical devices and therapeutic goods in Western Australia with 20–99 employees?
- 53 obligations apply (18 critical) across 25 regulators, plus 13 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; 18 critical obligations apply.
- Which Western Australia laws apply?
- PCBU primary duty of care (WA WHS Act 2020 s 19)
Related
- Medical devices & therapeutic goods compliance in Western Australia
- Medical devices & therapeutic goods: all obligations
- Compliance obligations by industry, state and size
- Medical devices & therapeutic goods in WA: sole trader
- Medical devices & therapeutic goods in WA: sole trader with employees
- Medical devices & therapeutic goods in WA: partnership
- Medical devices & therapeutic goods in WA: trading trust
- Medical devices & therapeutic goods in WA: no employees
- Medical devices & therapeutic goods in WA: 1–5 employees
- Medical devices & therapeutic goods in WA: 100–499 employees
- Medical devices & therapeutic goods in WA: 20–99 employees, turnover $1M–$3M
- Medical devices & therapeutic goods in WA: 6–19 employees, turnover $3M–$10M
- Medical devices & therapeutic goods in WA: 100–499 employees, turnover $100M–$1B
- Medical devices & therapeutic goods in WA: 500+ employees, turnover $1B+
- Medical devices & therapeutic goods in New South Wales: 20–99 employees
- Medical devices & therapeutic goods in Victoria: 20–99 employees
- Medical devices & therapeutic goods in Queensland: 20–99 employees
- Medical devices & therapeutic goods in South Australia: 20–99 employees
- Medical devices & therapeutic goods in Tasmania: 20–99 employees
- Medical devices & therapeutic goods in Northern Territory: 20–99 employees
- Medical devices & therapeutic goods in Australian Capital Territory: 20–99 employees
- 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
- RevenueWA: payroll tax thresholds and rates
- PCBU primary duty of care (WA WHS Act 2020 s 19)
- 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)
- Pay employees in accordance with the applicable modern award
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.