Check Medical Device CDSCO Class
| Medical Device Name | Risk Class | Intended Use | Category | Notification |
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Classification of Medical Devices in India
Class A
Low Risk Devices
Class B
Moderate-Low Risk Devices
Class C
Moderate-High Risk Devices
Class D
High Risk Devices
Class A (Low Risk) Medical Devices
- Medical Devices that pose minimal potential harm to the user.
- Regulation: Subject to general controls and may be exempt from premarket notification.
- Examples: Elastic Adhesive Bandages, examination gloves, absorbent cotton, and some hand-held surgical instruments.
- Safety Concern: Least potential for harm; mostly external use.
Class B (Low Moderate Risk)
- Definition: Devices with a higher risk than Class A and require greater regulatory controls to provide a reasonable assurance of safety and effectiveness.
- Regulation: Subject to general controls and may need special controls like patient registries for implantable devices.
- Example: Hypodermic needles, suction equipment, thermometer, catheter, IV canula, and blood pressure monitoring devices.
- Safety Concern: Potential harm is moderate; can be both external and internal devices.
Class C (Moderate-High Risk)
- Definition: Devices that have a higher risk than Class B and are usually implantable or life-supporting.
- Regulation: Subject to general controls, special controls, and MD9 licensing.
- Example: Bone plates, powered wheelchairs, and infusion pumps.
- Safety Concern: Can cause significant harm; often implantable or life-sustaining.
Class D (High Risk)
- Definition: Devices that sustain or support life, are implanted, or present a potentially unreasonable risk of illness or injury.
- Regulation: Subject to the strictest regulatory controls and require premarket approval.
- Examples: Heart valves, implantable pacemakers, ventilators, etc.
- Safety Concern: Highest potential for harm; critical for life support or sustenance.