GxPlex

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TGA SaMD

TGA regulation of software as a medical device

not yet verified

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 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 (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.

Observation history

No observations recorded yet.

Sources