GxPlex

Subject (as stated): artificial intelligence

13 of 86 tracked instruments.

This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.

Status unknown 1 frozen 3 draft 2 final 6 in-force 1

Ordered by the lifecycle the values themselves name.

Jurisdiction International 6 EU 3 US 2 Brazil 1 China 1

Ordered by count, then alphabetically.

Class (as stated) no self-stated class 7 consensus standard 3 authority guidance 2 legal act 1

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Showing 13 of 86 instruments. Clear all filters

Subject (as stated): artificial intelligence — 13 instrument(s) — no change has been detected yet, so rows are alphabetical; they order by change date as soon as one is
Instrument Authority Jurisdiction Status Last verified Last changed Source
ANVISA Agência Nacional de Vigilância Sanitária Brazil not yet verified frozen listing only link (opens in new tab)
EMA AI reflection paper European Medicines Agency EU final check unrecorded 2026-07-28 link (opens in new tab) · retrieved
EU AI Act European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
EU GMP Annex 22 European Commission EU not yet verified awaiting link (opens in new tab)
FDA AI guidance US Food and Drug Administration US draft — recorded as draft against the primary source verified 2026-07-30 link (opens in new tab) · retrieved
FDA CDRH AI/ML US Food and Drug Administration US draft — recorded as draft against the primary source verified 2026-07-30 link (opens in new tab) · retrieved
GAMP AI Guide ISPE International not yet verified frozen paywalled — progression tracked link (opens in new tab)
IMDRF AI/ML WG International Medical Device Regulators Forum International not yet verified frozen blocks automated requests link (opens in new tab)
ISO/IEC 22989 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 24028 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 42001 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
NMPA National Medical Products Administration China final verified 2026-07-28 link (opens in new tab) · retrieved
WHO AI health World Health Organization International final tool-read 2026-07-30 link (opens in new tab) · retrieved

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