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TGA Software-Based

Software-Based Medical Devices

Regulatory Changes for Software-Based Medical Devices (PDF)
AustraliaTherapeutic Goods AdministrationSoftware/SaMD
Official source linked
What this code is

Software-Based Medical Devices is the official TGA identifier for “Regulatory Changes for Software-Based Medical Devices (PDF)”. Software-Based Medical Devices is the official identifier TGA uses for this instrument.

Instrument
Software-Based
Full name
Software-Based Medical Devices
Category
Software/SaMD
Source links
Authority source
English
Open the issuing-authority text
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
Not available yet
This instrument page →
Use the official source while a readable HTML version is being prepared.
Dates
Published
June 2024
Effective
—
About this regulation

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-Based Medical Devices is the official identifier TGA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

Verified