What Australia TGA - Therapeutic Goods (Medical Devices) Regulations 2002 (2026 Reforms) requires
The Therapeutic Goods Administration (TGA) regulates medical devices and SaMD under the Therapeutic Goods Act 1989 and Regulations 2002. 2026 reforms introduce strengthened cybersecurity requirements, AI-specific guidance, mandatory unique device identification (UDI), enhanced post-market surveillance, and alignment with IMDRF principles. Devices are classified A-D with conformity assessment procedures scaled to risk.
Pillar: Medical & Healthcare · Authority: Therapeutic Goods Administration (TGA) · Version: 1.0.0 · Last updated:
Primary source: https://www.tga.gov.au/
SHA-256 integrity: 6e8b38a4092395f79795f196a915576be2ad36709e6fa1d660a7ae573f73b4db
Primary Citations — 4 traced to source
- Therapeutic Goods (Medical Devices) Regulations 2002 (as amended 2026)
- TGA Guidance on Software as a Medical Device (SaMD)
+ 2 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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