GxPlex

TGA SaMD

TGA regulation of software as a medical device

not yet verified

Last verified: not yet verified Last observed: no observation recorded Tier: 1 · Sector: medical device

Not yet verified. The status of this instrument has not been confirmed against its primary source. It is recorded as unknown rather than estimated. Consult the primary source (opens in new tab) directly.

Authority
Therapeutic Goods Administration
Jurisdiction
Other
Status
not yet verified
Effective date
—
Last changed
—
Last verified
: not yet verified
Watch cadence
quarterly
Crawlable
unknown
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) tga.gov.au

Current status#

Status not yet verified against the primary source. Recorded as unknown rather than estimated.

Scope#

TGA material addressing the regulation of software-based medical devices.

Sources#

NEEDS VERIFICATION. The regulatory status of this instrument has not yet been confirmed against its primary source. It is recorded as unknown rather than estimated. See /methodology for what verification means here.

Cite this instrument

Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. TGA regulation of software as a medical device [instrument record]. Observed 28 July 2026. https://gxplex.com/instrument/tga-samd Primary source: https://www.tga.gov.au/products/medical-devices/software-based-medical-devices

BibTeX

@misc{gxplexinstrumenttgasamd,
  author       = {{GxPlex}},
  title        = {{TGA regulation of software as a medical device}},
  year         = {2026},
  note         = {instrument record, observed 28 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/tga-samd}},
  urldate      = {2026-07-29},
  url          = {https://www.tga.gov.au/products/medical-devices/software-based-medical-devices}
}

APA

GxPlex. (2026). TGA regulation of software as a medical device [instrument record]. Retrieved 28 July 2026, from https://gxplex.com/instrument/tga-samd

Observation history

No observations recorded yet.

Sources