CDSCO Registration for Medical Devices & Cosmetics in India (2026)

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulator for drugs, medical devices, and cosmetics. Importing or manufacturing these products requires the correct CDSCO licence, applied for on the SUGAM portal.

Medical Device Risk Classes

Devices are classified by risk, which decides the licence and authority:

• Class A — low risk (e.g. surgical dressings).
• Class B — low-moderate risk (e.g. thermometers).
• Class C — moderate-high risk (e.g. implants).
• Class D — high risk (e.g. heart valves).

Key Licences

• MD-14/MD-15 (Import Licence): To import medical devices into India.
• MD-3/MD-5 (Manufacturing Licence): For Class A/B manufacturing (State Licensing Authority).
• MD-7/MD-9 (Manufacturing Licence): For Class C/D manufacturing (Central Licensing Authority).
• Cosmetics Import Registration (COS-1/COS-2): To import cosmetics for sale.

The Process

• Step 1: Appoint an Indian Authorised Agent (for importers) holding a wholesale licence.
• Step 2: Compile the technical dossier — device master file, plant master file, and quality certificates (ISO 13485, CE, or FDA).
• Step 3: File the application on SUGAM with fees.
• Step 4: Respond to queries; the licence is granted after review (and audit for higher classes).

Timeline

Import registrations typically take 6–9 months; manufacturing licences vary with class and audit requirements.

Statura guides importers and manufacturers through CDSCO licensing, and pairs it with ISO 13485 and BIS where required.