---
title: "PMDA Software-as-a-Medical-Device (SaMD) Pathway — KYE Protocol™ coverage"
description: "PMDA Software-as-a-Medical-Device (SaMD) Pathway coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it."
url: https://kyeprotocol.com/compliance/pmda-samd/
lang: en
source: "KYE Protocol"
---

> PMDA Software-as-a-Medical-Device (SaMD) Pathway coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

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

| Category | Reqs | Enforced | Designed | Advisory | Deferred | Coverage |
| --- | --- | --- | --- | --- | --- | --- |
| 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

| ID | Title | Status | KYE™ 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 2 unverified citations | **audit\_events**: `kye.resilience.drift.detected.v1` unverified citation, `kye.resilience.measurement_record.v1` unverified citation **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` |

Canonical KYE™ surfaces referenced on this page: [KYE Protocol™](https://kyeprotocol.com/).