PMDA Software-as-a-Medical-Device (SaMD) Pathway · vPharmaceuticals and Medical…

PMDA Software-as-a-Medical-Device (SaMD) Pathway

PMDA Software-as-a-Medical-Device (SaMD) Pathway — 90% of in-scope requirements covered.

5 requirements · 5 in scope (4 enforced · 1 designed). The 90% is weighted over the in-scope base.

Source: Pharmaceuticals and Medical Devices Agency (PMDA) Software-as-a-Medical-Device review pathway under the Pharmaceuticals and Medical Devices Act (PMD Act), including the SaMD two-step (DASH for SaMD) approval scheme and change-control expectations for AI/ML-enabled medical-device software. KYE™ maps the QMS evidence, clinical-evaluation provenance, change-control, post-market surveillance, and human-oversight obligations that bind an AI-supported clinical action onto runtime evidence; device classification and marketing approval remain the manufacturer's regulatory submission.

By category

CategoryReqsEnforcedDesignedAdvisoryDeferredCoverage
Quality management system evidence 1 1 0 0 0 100%
Clinical evaluation & provenance 1 1 0 0 0 100%
Change control & versioning 1 1 0 0 0 100%
Post-market surveillance & incident reporting 1 0 1 0 0 50%
Human oversight of clinical decisions 1 1 0 0 0 100%

Every requirement → the KYE™ artefact that enforces it

IDTitleStatusKYE™ enforcement
pmda-samd.qms-evidence PMDA SaMD — maintain quality-management-system evidence (design history, traceability, records) for the medical-device software lifecycle enforced audit_events: kye.evidence.pack.v1, kye.replay.context_seal.v1
engines: internal, internal
constitution_refs: constitution/30-AUDIT-WORM-RETENTION.md
pmda-samd.clinical-evaluation-provenance PMDA SaMD — substantiate clinical evaluation and the data provenance underpinning the device's intended use enforced audit_events: kye.evidence.tool_call.v1, kye.evidence.decision_map.v1
engines: internal, internal
constitution_refs: constitution/31-DATA-GOVERNANCE-PACK.md, constitution/13-RESILIENCE-LOOP.md
pmda-samd.change-control PMDA SaMD — operate change control over software versions and AI/ML model updates within the approved change-management scope enforced audit_events: kye.resilience.drift.detected.v1, kye.resilience.measurement_record.v1
engines: internal, internal
constitution_refs: constitution/13-RESILIENCE-LOOP.md
pmda-samd.post-market-surveillance PMDA SaMD — conduct post-market surveillance and report adverse events / malfunctions to the PMDA designed audit_events: kye.signal.incident.opened.v1, kye.compliance.attestation.v1
engines: internal, internal
constitution_refs: constitution/13-RESILIENCE-LOOP.md
pmda-samd.human-oversight PMDA SaMD — ensure clinically meaningful human oversight of AI-supported decisions in the intended-use environment enforced audit_events: kye.purpose.admissibility.v1, kye.evidence.decision_map.v1
engines: internal
constitution_refs: constitution/36-GOVERNEDUI.md, constitution/12-PURPOSE-PERMISSION.md