S0001RS1-T01-S0001-Z · Full risk code

High-Risk System Not Formally Registered

高風險系統未完成法定登錄

Inception
Risk Description

When a deploying organization introduces a high-risk AI system directly into a regulated market without confirming statutory registration obligations; due to the absence of pre-deployment compliance screening, the system is cited during supervisory inspection, triggering administrative sanctions, mandatory service suspension, business disruption, and severe reputational damage.

Framework Mappings

EU AI ActArt.49、Art.71
ISO/IEC 42001§4.1–4.2、Annex A.6.2.5
NIST AI RMFGOVERN 1.1
ISO/IEC 23894§6.3
ISO/IEC 5338部署
MIT AI Risk RepositoryDomain 6

Risk Treatment & Implementation Guidance

Maintain an organization-wide AI system inventory recording purpose, target markets and risk classification as the basis for determining registration obligations; Before deployment, verify completion of registration and pre-market requirements for each target market and assign accountable owners; Make completed statutory registration a mandatory release gate so that unregistered systems cannot go live