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# CDSCO Medical Device Classification (Class A/B/C/D)

India uses a four-class risk-based classification system for medical devices. Your device class determines everything: which import license form you need, whether notified body certification is required, how much clinical data you must submit, and how long approval will take.

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At a glance

Device classes

4

Classification rules

6

License forms

2

## Device classes at a glance

Class A

Risk: Low

Import License (MD-14) with self-registration or notified body certificate

**Examples:** Non-invasive devices: examination gloves, surgical instruments, wheelchairs, thermometers

**Testing:** Basic safety testing, often self-certified

Class B

Risk: Low-Moderate

Import License (MD-14) with notified body certificate required

**Examples:** Short-term invasive: hypodermic needles, catheters, suction equipment

**Testing:** Biocompatibility testing, sterilization validation

Class C

Risk: Moderate-High

Import License (MD-15) with full quality system audit

**Examples:** Long-term invasive or life-support: ventilators, infusion pumps, orthopedic implants

**Testing:** Extensive clinical evaluation, design verification, stability studies

Class D

Risk: High

Import License (MD-15) with extensive clinical trials data

**Examples:** Critical life-support: heart valves, implantable pacemakers, stents

**Testing:** Full clinical investigation, long-term implant studies, post-market surveillance

## Classification rules overview

Rule 1Non-invasive devices

Devices that do not penetrate body orifices

→ Generally Class A, unless connected to Class C/D devices

Rule 2Invasive devices - body orifices

Intended for short-term use (up to 60 minutes)

→ Class A if for oral/nasal/ear; Class B if for other orifices

Rule 3Invasive devices - short-term surgical

Intended for short-term use (up to 30 days)

→ Class B generally; Class C if connected to active device or modify biological activity

Rule 4Invasive devices - long-term

Intended for long-term use (more than 30 days)

→ Class C; Class D if life-supporting or critical implant

Rule 5-8Active devices

Devices requiring power supply

→ Varies by therapeutic/diagnostic purpose and energy delivery

Rule 9-13Special rules

Implantables, contraceptives, disinfectants, etc.

→ Specific rules for specialized device categories

## Import license forms by class

### Form MD-14

**Applicable:** Class A and B devices

**Requirements:** Device dossier, quality system documentation, manufacturing facility details

**Timeline:** 45-90 days after complete submission

### Form MD-15

**Applicable:** Class C and D devices

**Requirements:** Extensive dossier including clinical evaluation, post-market data, full quality system

**Timeline:** 90-180 days; may require additional information requests

## Device dossier sections

01Executive summary and device description

02Essential principles checklist

03Device design and manufacturing information

04Quality management system certification (ISO 13485)

05Risk management file (ISO 14971)

06Verification and validation documentation

07Clinical evaluation report

08Post-market surveillance plan

09Labeling and instructions for use

10Authorized Agent appointment documents

11Declaration of conformity

12Free Sale Certificate or export license from country of origin

## Frequently asked questions

### How do I determine which classification rule applies to my device?

Start with the intended use and characteristics of your device. Apply the classification rules sequentially from Rule 1. The first rule that applies determines your device class. If multiple rules could apply, use the rule that results in the higher classification. For complex devices, consult the Medical Device Rules 2017 Schedule 1 or seek guidance from CDSCO.

### Can a device have different classifications for different intended uses?

Yes. Classification depends on intended use. The same physical device can be Class A for one indication and Class C for another. You must declare all intended uses in your application. The highest applicable class determines your regulatory pathway. If you later add indications that increase the class level, you must update your license accordingly.

### What is the difference between self-registration and notified body certification for Class A?

Class A non-sterile, non-measuring devices can be self-registered by the manufacturer without notified body involvement (MDS-1 license). Class A sterile or measuring devices, and all Class B/C/D devices, require notified body certification. Self-registration is faster but only applies to the lowest-risk devices. Check the specific rules for your device type.

### Do I need Indian clinical trials for all device classes?

No. CDSCO typically accepts clinical data from other countries if the device has been marketed abroad with acceptable safety records. Indian clinical trials may be required for: (1) Class D devices without substantial foreign clinical data, (2) novel devices without predicate, (3) devices with significant design differences from foreign-marketed versions. Class A and B devices rarely require Indian trials.

### What happens if CDSCO disagrees with my classification?

CDSCO may reclassify your device during review if they determine a higher risk class applies. This typically results in: (1) application put on hold pending additional documentation, (2) requirement for notified body certificate if not originally submitted, (3) request for clinical data if device moved to Class C/D. You cannot sell the device until reclassification issues are resolved and appropriate license obtained.

**Disclaimer:** This guide reflects the Medical Device Rules 2017 classification framework. Classification determinations should be verified against current CDSCO notifications and guidance documents. For borderline cases, consult qualified regulatory professionals.

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