---
title: "CDSCO Medical Devices Rules 2017 — KYE Protocol™ coverage"
description: "CDSCO Medical Devices Rules 2017 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it."
url: https://kyeprotocol.com/compliance/cdsco-medical-devices/
lang: en
source: "KYE Protocol"
---

> CDSCO Medical Devices Rules 2017 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

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

| Category | Reqs | Enforced | Designed | Advisory | Deferred | Coverage |
| --- | --- | --- | --- | --- | --- | --- |
| CDSCO Medical Devices Rules 2017 | 5 | 2 | 0 | 0 | 0 | **100%** |

## Every requirement → the KYE™ artefact that enforces it

| ID | Title | Status | KYE™ 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` |

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