Check Medical Device CDSCO Class
| Medical Device Name | Risk Class | Intended Use | Category | Notification |
|---|
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.
- License Required:
- For Non Sterile Non Measuring Devices – Class A Registration
- For Sterile or Measuring Products – MD5 License
- 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.
- License Required: MD5 License
- 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.
- License Required: MD9 License
- 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.
- License Required: MD9 License
- 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.
Frequently Asked Questions (FAQs)
Which license is required for manufacturing Class A Medical Devices?
For Non Sterile Non Measuring Class A Medical Devices – CDSCO Class A Registration is required
For Sterile or Measuring Class A Medical Devices – MD5 License is required
Which license is required for manufacturing Class B Medical Devices?
CDSCO MD5 License is required for Class B Medical Devices.
Which license is required for manufacturing Class C Medical Devices?
CDSCO MD9 License is required for manufacturing Class C Medical Devices.
Which license is required for manufacturing Class D Medical Devices?
CDSCO MD9 License is required for manufacturing Class D Medical Devices.
Which license is required to import Class A Medical Devices?
For Non Sterile Non Measuring Devices – CDSCO Class A registration is required
For Sterile or Measuring Class A Devices – MD15 License is required
Which license is required to import Class B, C & D Medical Devices?
CDSCO MD15 License is required to import Class B, C & D Medical Devices
Do I need CDSCO license for Class A Non-sterile Non-measuring medical devices?
No, only CDSCO Class A registration is required to manufacture or import Class A Non Sterile Non Meassuring Medical Devices
What is government fee for CDSCO MD5 License?
The government fees for MD5 License is –
- Rs 5000 per application
- Rs 500 per product
What is government fee for CDSCO MD9 License?
The government fees for MD5 License is –
- Rs 50,000 per application
- Rs 1,000 per product
What is government fee for CDSCO MD15 import License?
The government fees for CDSCO MD15 Import License is –
- Class A Sterile/Measuring Products – $1,000 per site & $50 per product
- Class B Medical Devices – $2,000 per site & $1,000 per product
- Class C & D Medical Devices – $3,000 per site & $1,500 per product
Do you need Medical Device Manufacturing or Import License? We can help you get it easily!