Do sole traders need to conduct post-market surveillance of therapeutic goods?

Yes. Looking in medical devices & therapeutic goods and every size band, the engine's answer for a sole trader is: yes.

Do businesses with 1–5 employees need to conduct post-market surveillance of therapeutic goods?

Yes (1–5 employees, turnover $100K–$1M).

Who must conduct post-market surveillance of therapeutic goods?

The applicability test for Conduct post-market surveillance of therapeutic goods (TGA), computed across 35 industries, 9 business structures and 6 size bands.

Short answer: Some businesses

Applies when the business has industry: Medical devices & therapeutic goods.

What the obligation is

ARTG-included goods must be monitored post-market for safety + performance.

Part 5-1 Therapeutic Goods Act + ARTG conditions require sponsors to conduct post-market surveillance — adverse-event reporting, safety updates, recall when warranted. Medical-device manufacturers operate quality management systems aligned to ISO 13485 with TGA conformity assessment.

The applicability test

Applies when the business has industry: Medical devices & therapeutic goods.

How the regulator frames it: ARTG sponsors + manufacturers (medicines + devices + biologicals).

What triggers it: Inclusion of goods in the ARTG.

Jurisdiction: Commonwealth law, so the test is the same in every state and territory.

Which industries are in or out

Outcome across the 35 industries Rules Mate maps (1 of 35: yes; 34 of 35: no).

Industry	Answer
Medical devices & therapeutic goods	Yes
No	34 other industries

Business structure and size

Structure does not change the answer in medical devices & therapeutic goods: for every structure the answer is "yes".

Size does not change the answer in medical devices & therapeutic goods: at every size band the answer is "yes".

Worked examples

Each line is one run of the Rules Mate applicability engine for a single business profile, with the reason the engine gives:

Pty Ltd company in medical devices & therapeutic goods with 6–19 employees, turnover $1M–$3M: applies. Industry: Medical devices & therapeutic goods.
Pty Ltd company in real estate agents with 6–19 employees, turnover $1M–$3M: does not apply. Requires industry: Medical devices & therapeutic goods.

What you must do, and when

When due: Continuous; adverse-event reports per timeframes; periodic safety updates.
Frequency: Ongoing
Evidence to keep: PMS plan; adverse-event register; safety updates; recall procedure.
Status: Current
Priority: Critical

Penalty for not complying

Maximum penalty: Civil + criminal penalties (civil up to $1.82M individual / $18.2M body corporate); ARTG cancellation.

Criminal liability

Breaches can be prosecuted as criminal offences, not only civil contraventions.

Audit or assurance level

Rules Mate has not yet classified the audit or assurance level for this obligation. Any audit, review or certification requirement is set by the regulator source listed below.

Enforcement examples

TGA cancellations + recalls — medical devices 2024 (2024): Medical device sponsors must active PMS + report adverse events promptly; ARTG cancellation kills market access.

Obligations with the same applicability test

If this obligation applies to you, so does this one: the engine uses the same rule for each.

In-vitro diagnostic medical device classification + ARTG

What usually applies alongside it

Across the 1,890 business profiles Rules Mate evaluates, these obligations apply to most of the businesses this one applies to, and are far more common among them than among businesses generally:

Where it sits in the corpus

Rules Mate tracks 4 published obligations tagged "medicines", 4 of them rated critical. For a professional services Pty Ltd company with 6–19 employees operating in every state, 0 of those apply outright. This obligation is rated critical priority and carries criminal liability, and is an ongoing duty.

Regulator, legislation and tools

Regulated by Therapeutic Goods Administration.

TGA: Regulator of therapeutic goods — medicines, medical devices, biologicals, and blood products. Administers the Therapeutic Goods Act and ARTG.

Therapeutic Goods Administration

Therapeutic Goods Act 1989: Federal Therapeutic Goods Administration regime.

Therapeutic Goods Act 1989

Free tools that help with this obligation:

Compliance calendar builder

Run the compliance journeyAnswer a short questionnaire about your business and get the obligations that apply to you, with the reason each one applies.

Questions

Who must conduct post-market surveillance of therapeutic goods?: Applies when the business has industry: Medical devices & therapeutic goods.
Do sole traders need to conduct post-market surveillance of therapeutic goods?: Yes. Looking in medical devices & therapeutic goods and every size band, the engine's answer for a sole trader is: yes.
Do businesses with 1–5 employees need to conduct post-market surveillance of therapeutic goods?: Yes (1–5 employees, turnover $100K–$1M).
When is "Conduct post-market surveillance of therapeutic goods" due?: Continuous; adverse-event reports per timeframes; periodic safety updates.

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.