/**
 * AU TGA Software as a Medical Device (SaMD)
 *
 * Primary legislation: Therapeutic Goods Act 1989 (Cth); Therapeutic Goods
 * (Medical Devices) Regulations 2002.
 *
 * Key instruments:
 *   - TGA Regulatory Guidance: Software as a Medical Device (updated 2023)
 *   - TGA AI/ML-enabled Medical Devices Guidance (2023, updated 2024)
 *   - IMDRF SaMD Key Definitions (N10, 2013); Risk Categorisation (N12, 2014)
 *   - Good Machine Learning Practice (GMLP) Principles (TGA adopted 2021/2023)
 *   - TGA Unique Device Identification (UDI) system
 *
 * Covered: Software meeting "medical device" definition: diagnosis, prevention,
 * monitoring, prediction, prognosis, treatment, alleviation of disease/injury.
 * AI/ML CDS in IMDRF SaMD Categories II-IV. Adaptive AI/ML algorithms require
 * enhanced pre-market review + post-market change management.
 *
 * IMDRF Risk Classification (TGA-adopted):
 *   I: Non-serious / Treat+diagnose
 *   II: Non-serious / Drive clinical management
 *   III: Serious / Inform clinical management
 *   IV: Critical / Treat+diagnose directly
 *
 * [CITATION TO VERIFY]:
 *   - Some IMDRF Category I software may be excluded under current TGA excluded
 *     software determination — verify current scope.
 *   - Pure data-consolidation CDS without analysis — verify scope alignment with
 *     updated 2023 TGA guidance.
 *
 * Key AI obligations:
 *   - TGA Registration: SaMD on ARTG before AU supply. s.41MA offence to supply
 *     unregistered. FDA clearance does NOT substitute for ARTG.
 *   - GMLP 10 Principles: Multi-disciplinary teams, clinical-AI collaboration,
 *     real-world deployment design, data management transparency, reference
 *     datasets, tailored model testing, human-AI teaming, contextualised
 *     performance testing, inform users of limitations, deployed model monitoring.
 *   - PCCP: Predetermined Change Control Plan for adaptive models; significant
 *     changes require pre-market notification or new conformity assessment.
 *   - Post-Market Surveillance: Real-world performance monitoring with drift
 *     detection; adverse events reported.
 *   - Adverse events: 10 calendar days for incidents likely causing death/serious
 *     deterioration; 30 days for incidents that could have caused death/serious
 *     injury.
 *
 * Cross-pack interactions:
 *   - au-tga-saimd + fda-samd: Sequential separate requirements; TGA-FDA mutual
 *     recognition for assessment bodies (not approvals). ISO 13485 satisfies both
 *     QMS requirements. FDA PCCP and TGA PCCP differ in detail — both reviewed
 *     separately. More demanding risk classification governs overall governance.
 *   - au-tga-saimd + hipaa: AU SaMD on platforms processing US patient data:
 *     HIPAA BAA covers US-side; Privacy Act APPs cover AU-side. Both required.
 *   - au-tga-saimd + au-privacy-act: Patient clinical data in SaMD = health info
 *     under Privacy Act (sensitive info — APP 3.3 explicit consent). TGA Essential
 *     Principles + APP 11 security both apply. Stricter TGA 10-year retention
 *     governs overlapping records.
 *   - au-tga-saimd + au-mandatory-ai-guardrails: Healthcare = proposed high-risk
 *     setting. TGA SaMD with GMLP, PCCP, clinical evidence, post-market monitoring
 *     satisfies most proposed guardrails for healthcare.
 *
 * Authority: Therapeutic Goods Administration (TGA) — Department of Health and
 *   Aged Care
 * Sovereignty: Australian Federal
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
export declare const AU_TGA_SAIMD_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const AU_TGA_SAIMD_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
    subjectKeyedCategories: string[];
};
//# sourceMappingURL=au-tga-saimd.d.ts.map