Do medical devices and therapeutic goods need to conduct post-market surveillance of therapeutic goods?
A computed answer from the Rules Mate applicability engine, with the exact condition, the outcome for every structure and size, and the primary source.
Short answer: Yes
Yes. This obligation applies to medical devices and therapeutic goods whatever their structure or size. The deciding fact: Industry: Medical devices & therapeutic goods.
The obligation in brief
Conduct post-market surveillance of therapeutic goods. 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.
Trigger: Inclusion of goods in the ARTG.
Why medical devices & therapeutic goods get a different answer
Rules Mate runs its applicability engine across 9 business structures and 6 size bands for each of the 35 industries it maps. For 34 of those industries the answer for "Conduct post-market surveillance of therapeutic goods" is no. Medical devices & therapeutic goods is one of the 1 where the answer is different: yes.
The deciding fact for medical devices and therapeutic goods: Industry: Medical devices & therapeutic goods.
About the industry: Suppliers of therapeutic goods listed on the ARTG.
Compare a professional services (general) business with 6–19 employees structured as a Pty Ltd company: the obligation does not apply (Requires industry: Medical devices & therapeutic goods).
Answer by business structure and size
Each cell is the engine's outcome for a business in medical devices & therapeutic goods with that structure and size, assuming it sells to consumers and small businesses and holds customer contact details. "Check" means the obligation turns on a fact the industry does not settle.
| Structure | No employees | 1–5 employees | 6–19 employees | 20–99 employees | 100–499 employees | 500+ employees |
|---|---|---|---|---|---|---|
| Sole trader | Yes | Yes | Yes | Yes | Yes | Yes |
| Partnership | Yes | Yes | Yes | Yes | Yes | Yes |
| Trust | Yes | Yes | Yes | Yes | Yes | Yes |
| Pty Ltd company | Yes | Yes | Yes | Yes | Yes | Yes |
| Public company | Yes | Yes | Yes | Yes | Yes | Yes |
| Not-for-profit (unregistered) | Yes | Yes | Yes | Yes | Yes | Yes |
| Registered charity | Yes | Yes | Yes | Yes | Yes | Yes |
| Super fund | Yes | Yes | Yes | Yes | Yes | Yes |
| Foreign company | Yes | Yes | Yes | Yes | Yes | Yes |
What the obligation requires
- When due
- Continuous; adverse-event reports per timeframes; periodic safety updates.
- Evidence to keep
- PMS plan; adverse-event register; safety updates; recall procedure.
- Maximum penalty
- Civil + criminal penalties (civil up to $1.82M individual / $18.2M body corporate); ARTG cancellation
- Regulator
- TGA
- Jurisdiction
- Commonwealth (national)
Other obligations where medical devices & therapeutic goods differ from the norm
- In-vitro diagnostic medical device classification + ARTG: Yes
- Comply with anti-dumping + countervailing duties: Only if
- Comply with self-assessed clearance + Integrated Cargo System (ICS): Only if
- Comply with the Therapeutic Goods Advertising Code: Yes
- Customs Act 1901 — import declarations + duties: Only if
- Notify ACCC of a voluntary recall within 2 days: Yes
- All 8 answers for medical devices & therapeutic goods
Questions
- Do medical devices and therapeutic goods need to conduct post-market surveillance of therapeutic goods?
- Yes. This obligation applies to medical devices and therapeutic goods whatever their structure or size. The deciding fact: Industry: Medical devices & therapeutic goods.
- Is the answer the same for every industry?
- No. For 34 of the 35 industries Rules Mate maps, the answer is no. Medical devices & therapeutic goods is one of 1 industries with a different answer.
Related
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.