CDSCO Medical Devices Rules 2017 · vMedical Devices Rules, 2017…

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.

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 2017 5 2 0 0 0 100%

Every requirement → the KYE™ artefact that enforces it

IDTitleStatusKYE™ enforcement
cdsco-medical-devices.CLINICAL-ACTION-AUTHORITY Clinical actions by software resolve to a live authority and are evidenced enforced audit_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-EVIDENCE Records supporting post-market surveillance and adverse-event review enforced audit_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-CLASSIFICATION Risk-based classification of the device out-of-scope constitution_refs: constitution/70-FRAMEWORK-MAPPING-RAIL.md
cdsco-medical-devices.LICENSING Manufacturing or import licence obtained and maintained out-of-scope constitution_refs: constitution/70-FRAMEWORK-MAPPING-RAIL.md
cdsco-medical-devices.QMS Quality management system for design and manufacture out-of-scope constitution_refs: constitution/70-FRAMEWORK-MAPPING-RAIL.md