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Medaloft
17 May 2026
Classification of Medical Devices in India
Medical devices in India are classified into 4 risk-based classes (A to D) under the Medical Device Rules, 2017 — determining licensing authority and approval pathway.
Medical devices in India are classified based on risk:
| Class | Risk Level | Examples |
|---|---|---|
| Class A | Low Risk | Surgical dressings, thermometers, tongue depressors |
| Class B | Low to Moderate Risk | Syringes, suction equipment, blood pressure monitors |
| Class C | Moderate to High Risk | Ventilators, infusion pumps, orthopedic implants |
| Class D | High Risk | Heart valves, implantable pacemakers, life-supporting devices |
The applicable licensing authority depends on the class of the medical device and whether the product is manufactured in India or imported.