Medical Device Registration in India — CDSCO Class A to D

Medical Device Classification Under MDR 2017

Under India’s Medical Devices Rules (MDR), 2017, all medical devices are classified into four risk-based categories:

• Class A — Lowest risk (bandages, tongue depressors, basic surgical instruments). Class A NSNM (Non-Sterile, Non-Measuring) now under self-notification on SUGAM.
• Class B — Low-moderate risk (hypodermic needles, sutures, blood pressure monitors). Licensed by State Licensing Authorities.
• Class C — Moderate-high risk (dialysis machines, surgical lasers, ventilators). CDSCO Central Licensing Authority approval required.
• Class D — Highest risk (implantable cardiac devices, HIV diagnostics). CDSCO Central Licensing Authority approval required.

CDSCO Medical Device Registration Process

For Domestic Manufacturers (Class C & D)

Manufacturing license (Form MD-3, MD-5, MD-7, or MD-9) from CDSCO CLA, requiring ISO 13485 alignment, technical documentation, and GMP compliance.

For Importers (MD-14 / MD-15)

Form MD-14 is the import license application; Form MD-15 is the issued import license. Requires Device Master File (DMF), Plant Master File (PMF), free sale certificate from country of origin, and ISO 13485 certification.

IVD Registration

In-vitro diagnostic devices have their own CDSCO classification and pathway. Since 2025, IVDs in Class B–D require mandatory In-Country Performance Evaluation in CDSCO-recognised labs before import registration.

2025 CDSCO Regulatory Updates Affecting Your Application

• October 2025: All Class C and D devices now mandatorily require CDSCO registration (even previously non-notified categories)
• Class A NSNM devices: Streamlined to self-notification via SUGAM — no full CLA review needed
• New Risk Classification Module launched on SUGAM portal (November 2025): Simplifies device classification requests before full applications
• IVD importers: In-Country Performance Evaluation now mandatory for Class B–D IVDs