What Guidance on Digital Health Technologies - Software as a Medical Device (SaMD) Classification, Advertising Rules and Post-Market Monitoring requires
This guidance outlines the Therapeutic Goods Administration's (TGA) regulatory framework for Software as a Medical Device (SaMD) in Australia, including classification rules based on risk, advertising requirements under the Therapeutic Goods Advertising Code, and post-market monitoring obligations under the Therapeutic Goods Act 1989. It applies to sponsors and developers of digital health software intended for medical purposes, particularly those seeking inclusion in the Australian Register of Therapeutic Goods (ARTG). Key provisions are derived from the Therapeutic Goods (Medical Devices) Regulations 2002 and the TGA's interpretation of SaMD under the IMDRF framework.
Pillar: Medical & Healthcare · Authority: Therapeutic Goods Administration (TGA), Department of Health and Aged Care, Australian Government · Version: 1.0.1 · Last updated:
Primary source: https://www.tga.gov.au/resources/resource/guidance/digital-health-technologies
SHA-256 integrity: 87df3d13b332eced9ffebb4da6e0fef7787a136e19c150c773a97b55d489de3f
Primary Citations — 5 traced to source
- TGA Guidance on Digital Health Technologies 2023, Section 2.1 - Definition of a medical device
- TGA Guidance on Digital Health Technologies 2023, Section 3.2 - SaMD Classification Criteria
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/australia-tga-digital-health-guidance-2023.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/australia-tga-digital-health-guidance-2023.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/australia-tga-digital-health-guidance-2023
- Back to registry: Browse all 10,090 compliance nodes