Australia medical device regulations
Official sources linkedTGA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Therapeutic Goods (Medical Devices) Regulations 2002 | Therapeutic Goods (Medical Devices) Regulations 2002 Current FRL compilation F2026C00610 (compilation 71, start 1 July 2026) of Statutory Rules No. 236, 2002. Series F2002B00237. Ingested from the official EPUB, including Essential Principles and classification-rule schedules. | General | October 3, 2002 | Official |
| Therapeutic Goods Act 1989 | Therapeutic Goods Act 1989 Current FRL compilation C2025C00525 (compilation 89, start 5 September 2025) of Act No. 21, 1990. Official series id C2004A03952. Section 2 ties commencement to parliamentary approval rather than the assent year, so no unsupported effective date is asserted. The previous metadata URL C2017C00225 was an old compilation id. Currentness re-verified 2026-09-07: the FRL documents API still reports C2025C00525 (compilation 89, start 2025-09-05, rectification 0) as the newest EPUB expression and the official 394,994-byte EPUB re-fetched byte-identical to the stored SHA-256. | General | — | Official |
| Medical Devices Regulations 2002 | Therapeutic Goods (Medical Devices) Regulations 2002 - TGA Summary TGA summary page, not the FRL instrument. Full text is au-legislation-full. | General | — | Official |
| ARGMD | Australian Regulatory Guidelines for Medical Devices (ARGMD) TGA guidance index, not the Act or Regulations. Not ingested in this FRL family. | General | — | Official |
| Standards & Guidelines | Standards, Guidelines & Publications for Medical Devices and IVDs TGA publications collection page. Not ingested. | General | — | Official |
| Medical Devices Reforms | Medical Devices Reforms - Regulatory Changes TGA reforms overview page. Not ingested. | General | — | Official |
| Health Practitioner Guidance | Regulatory Basics for Health Practitioners (PDF) Exact TGA PDF locator, not yet ingested: re-probed 2026-08-29 and tga.gov.au serves an IP-reputation block page (reference 18.871c1602.1788047640.d5806fdf) to every egress available to this project — direct HTTP/2 (stream reset), HTTP/1.1 (tarpit), datacenter Browserless (block page), and stealth /unblock (solved:false, 403). Ingest from AU/residential egress or after a TGA WAF reputation change. | General | — | Official |
| Software-Based Medical Devices | Regulatory Changes for Software-Based Medical Devices (PDF) Exact TGA PDF locator, not yet ingested: re-probed 2026-08-29 and tga.gov.au serves an IP-reputation block page (reference 18.871c1602.1788047640.d5806fdf) to every egress available to this project — direct HTTP/2 (stream reset), HTTP/1.1 (tarpit), datacenter Browserless (block page), and stealth /unblock (solved:false, 403). Ingest from AU/residential egress or after a TGA WAF reputation change. | Software/SaMD | — | Official |
| Animal Origin Devices | Medical Devices Containing Medicinal/Animal Origin Substances TGA guidance page. Not ingested in this FRL family. | General | — | Official |
| Processing Timeframes | Understanding Processing Timeframes for Medical Device Applications TGA guidance page. Not ingested in this FRL family. | Registration | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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