🇮🇳India Medical Device Regulations

Medical Devices Acts and Rules Collection

Collection of acts and rules related to medical device regulation including amendments and notifications.

Registration and Import License for Medical Devices

Requirements for registration and import licenses for medical devices. Foreign manufacturers must appoint an authorized Indian agent.

SUGAM Online Portal for Medical Devices

SUGAM is the online portal for medical device applications including registration, import licenses, and manufacturing approvals. All applications must be submitted online.

Medical Devices Rules, 2017

Primary rules governing medical devices in India. Establishes classification system (Class A-D), registration requirements, and import/manufacturing licenses.

Central Drugs Standard Control Organisation - Medical Devices

CDSCO regulates medical devices in India under the Ministry of Health and Family Welfare. Covers device registration, import licenses, and manufacturing approvals.

Medical Device Classification in India

India uses GHTF-aligned classification: Class A (low risk), Class B (low-moderate), Class C (moderate-high), Class D (high risk). Classification determines registration pathway.