CDSCO Device Classification Checker

What type of medical device are you seeking to register?

Select the category that best describes your device. This will guide the initial classification pathway.

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Implantable Device

Stents, grafts, occluders, leads, prostheses — devices intended to remain in the body

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Interventional / Surgical

Catheters, guidewires, delivery systems, surgical instruments used in procedures

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Diagnostic / Imaging

IVD, imaging equipment, monitoring devices, diagnostic software

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Active Therapeutic

Neuromodulation, ablation, electrosurgery, powered implants

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Consumable / Disposable

Single-use devices, wound care, IOLs, tubing, drapes

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Software as Medical Device

Clinical decision support, AI diagnostics, device control software

Risk characteristics of your device

Select all that apply. These factors determine whether your device is classified at a higher risk level under CDSCO rules.

Device comes into contact with blood or body fluids

Device is used in or near the central cardiovascular or central nervous system

Device is intended to sustain or support life

Device delivers energy to the patient (electrical, thermal, radiation)

Device contains a biological component, drug, or human tissue derivative

Device is supplied sterile or intended to be used in a sterile field

How long is the device intended to be used or remain in the body?

Duration of contact or implantation is a key classification factor under Medical Devices Rules 2017.

Transient — Less than 60 minutes

Single-use during a procedure — guidewires, catheters used briefly

Short Term — 60 minutes to 30 days

Post-procedure monitoring devices, temporary implants, wound dressings

Long Term — More than 30 days

Permanent implants, long-term indwelling devices, chronic condition devices

Not Applicable — External use only

Diagnostic equipment, external monitors, software — no direct body contact

CDSCO Classification

High Risk

Regulatory Authority

CDSCO — Central Drugs Standard Control Organisation

Applicable Rules

Medical Devices Rules 2017 (Amended 2020)

Estimated Timeline

Clinical Investigation

Key Documentation Requirements

Need a precise classification opinion?

This tool provides indicative guidance only. Formal CDSCO classification requires detailed review of your technical specifications, intended use, and predicate device analysis. Our team provides definitive classification opinions as part of our regulatory pathway assessment.

Request Formal Assessment

CDSCO DeviceClassification Checker

Key Documentation Requirements

Need a precise classification opinion?