CDSCO Medical Devices Rules 2017

CDSCO Medical Devices Rules 2017 — 100% of in-scope requirements covered.

5 requirements · 2 in scope (2 enforced) · 3 out-of-scope (outside KYE™’s authority layer). The 100% is weighted over the in-scope base.

CDSCO Medical Devices Rules 2017: requirement → the KYE™ artefact that enforces it

Demo data

You learn: Which requirements KYE™ enforces at runtime and with which artefact. You can: Walk the requirements.

  1. CLINICAL-ACTION-AUTHORITY · enforced

    Clinical actions by software resolve to a live authority and are evidenced

    Audit events: kye.purpose.admissibility.v1, kye.evidence.decision_map.v1, kye.evidence.pack.v1, kye.replay.context_seal.v1, kye.compliance.attestation.v1 · Constitution: 12 purpose permission, 13…

  2. POST-MARKET-EVIDENCE · enforced

    Records supporting post-market surveillance and adverse-event review

    Audit events: kye.evidence.pack.v1, kye.replay.context_seal.v1, kye.compliance.attestation.v1 · Constitution: 30 audit worm retention

  3. DEVICE-CLASSIFICATION · out-of-scope

    Risk-based classification of the device

    Constitution: 70 framework mapping rail

  4. LICENSING · out-of-scope

    Manufacturing or import licence obtained and maintained

    Constitution: 70 framework mapping rail

  5. QMS · out-of-scope

    Quality management system for design and manufacture

    Constitution: 70 framework mapping rail

How this widget is built
Demonstrates
KYE™ Compliance Mapping Rail™
Components
  • Framework requirement (clause)
  • Coverage status
  • KYE™ enforcement artefact (event, decision-record field, Evidence Pack™ entry)
Flow
Clause → status → the KYE™ artefact that enforces it, enforced requirements first. Architecture diagram
Used on

Source: Central Drugs Standard Control Organisation (CDSCO), Medical Devices Rules, 2017, made under the Drugs and Cosmetics Act, 1940

By category

CategoryReqsEnforcedDesignedAdvisoryDeferredCoverage
CDSCO Medical Devices Rules 201752000100%

Every requirement → the KYE™ artefact that enforces it

IDTitleStatusKYE™ enforcement
cdsco-medical-devices.CLINICAL-ACTION-AUTHORITYClinical actions by software resolve to a live authority and are evidencedenforcedaudit_events: kye.purpose.admissibility.v1, kye.evidence.decision_map.v1, kye.evidence.pack.v1, kye.replay.context_seal.v1, kye.compliance.attestation.v1
engines: internal
constitution_refs: constitution/12-PURPOSE-PERMISSION.md, constitution/13-RESILIENCE-LOOP.md
cdsco-medical-devices.POST-MARKET-EVIDENCERecords supporting post-market surveillance and adverse-event reviewenforcedaudit_events: kye.evidence.pack.v1, kye.replay.context_seal.v1, kye.compliance.attestation.v1
constitution_refs: constitution/30-AUDIT-WORM-RETENTION.md
cdsco-medical-devices.DEVICE-CLASSIFICATIONRisk-based classification of the deviceout-of-scopeconstitution_refs: constitution/70-FRAMEWORK-MAPPING-RAIL.md
cdsco-medical-devices.LICENSINGManufacturing or import licence obtained and maintainedout-of-scopeconstitution_refs: constitution/70-FRAMEWORK-MAPPING-RAIL.md
cdsco-medical-devices.QMSQuality management system for design and manufactureout-of-scopeconstitution_refs: constitution/70-FRAMEWORK-MAPPING-RAIL.md

Canonical KYE™ surfaces referenced on this page: KYE Protocol™.