Regulatory Framework Overview
The three-layer structure
India's medical device regulation rests on three layers:
- Primary legislation — the Drugs and Cosmetics Act 1940, which provides the statutory basis for regulation of medical devices.
- Subordinate legislation — the Medical Devices Rules 2017 (MDR 2017), which contains the detailed licensing, classification, GMP, labelling, and vigilance requirements.
- Guidance and notifications — CDSCO office memoranda, circulars, and gazette notifications that expand device scope and clarify requirements.
Key legislation at a glance
| Instrument | Covers |
|---|---|
| Drugs and Cosmetics Act 1940 (D&C Act) | Statutory basis; definition; offences and penalties |
| Medical Devices Rules 2017 (MDR 2017) | Classification, import/manufacturing licences, GMP, labelling, vigilance, clinical investigation |
| New Drugs and Clinical Trials Rules 2019 (ND&CT Rules) | Clinical investigations for new devices |
| Drugs (Prices Control) Order 2013 (DPCO) | Price regulation for certain medical devices |
| Gazette notifications | Expansion of notified device categories; amendments |
The regulator: CDSCO
The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare is India's national medical device regulator. The head of CDSCO — the Drugs Controller General of India (DCGI) — acts as the Central Licensing Authority (CLA) for medical devices.
The SUGAM portal
All CDSCO-level applications (import licences, manufacturing licences for Class C/D, clinical investigation permissions) are submitted through the SUGAM online portal at sugam.cdsco.gov.in. See SUGAM Portal Guide for a step-by-step walkthrough.
Phased implementation
India's MDR 2017 has been implemented in phases, with additional device categories progressively notified under Schedule I and Schedule II. See Phased Implementation & Transition History for the timeline.