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Class A · B · C · D — Overview

Class A — Low risk​

Characteristics: Non-invasive; minimal or no direct contact with patient; lowest potential harm.

Examples: Tongue depressors, examination gloves, non-sterile wound dressings, walking frames, hospital furniture.

Licensing:

  • Import: Form MD-15 (registration / self-declaration)
  • Manufacture: State Licensing Authority (SLA)

GMP: Schedule 5 Part I (basic GMP requirements).

Class B — Low-to-medium risk​

Characteristics: Invasive (short-term or non-surgical), or active therapeutic devices with low risk.

Examples: Hypodermic needles, blood pressure monitors, infusion sets, hearing aids, breathing tubes.

Licensing:

  • Import: Form MD-14 via CDSCO / SUGAM
  • Manufacture: State Licensing Authority (SLA)

GMP: Schedule 5 Part I.

Class C — Medium-to-high risk​

Characteristics: Invasive for long-term use, implantable (non-cardiac), or active devices with significant energy delivery.

Examples: Spinal implants, vascular grafts, haemodialysis machines, long-term urinary catheters, ventilators.

Licensing:

  • Import: Form MD-14 via CDSCO / SUGAM
  • Manufacture: CDSCO

GMP: Schedule 5 Part I and additional requirements for the device type.

Class D — High risk​

Characteristics: Implantable cardiac/CNS devices, devices in direct contact with the central cardiovascular system, or life-sustaining devices.

Examples: Cardiac pacemakers, implantable defibrillators, drug-eluting coronary stents, neurostimulators, HIV diagnostic kits (IVD Class D).

Licensing:

  • Import: Form MD-14 via CDSCO / SUGAM
  • Manufacture: CDSCO

GMP: Schedule 5 Part I and Part II (full quality system requirements comparable to ISO 13485).