Device classification
The risk class of your device decides who licenses it, the fees and the audits.
- Dealers, distributors and online sellers
- Importers and Indian manufacturers
- Medical devices and IVDs only, under the Medical Devices Rules, 2017
CDSCO medical device guide: all topics
- CDSCO medical device licences (overview)
- MD-42 sale and distribution registration
- Import licence (MD-14 / MD-15)
- Manufacturing licence (MD-5 / MD-9)
- Device risk classification (Class A to D)
- CDSCO medical device FAQ
The four classes
| Class | Risk | Typical examples | Manufacturing licence from |
|---|---|---|---|
| A | Low | Bandages, tongue depressors, alcohol swabs | State Licensing Authority (MD-5) |
| B | Low to moderate | Hypodermic needles, suction equipment | State Licensing Authority (MD-5) |
| C | Moderate to high | Ventilators, bone fixation plates | CDSCO (MD-9) |
| D | High | Heart valves, implantable defibrillators | CDSCO (MD-9) |
Examples are illustrative. The class of your exact device is fixed by the First Schedule rules and the classification lists CDSCO publishes; always check the current list for your product.
What the class decides
- Manufacturing authority: State for A/B, CDSCO for C/D
- Fees: per site and per device, higher for C/D
- Audit: notified body for A/B, CDSCO inspection for C/D
- Class A relief: non-sterile, non-measuring Class A devices are exempt from licensing but must be registered
How classification works
The First Schedule sets rules based on how long the device is used, whether it is invasive, active or implantable, and the part of the body involved. A device with more than one intended use takes the highest applicable class. We check your product range and give you a written classification before you file. Next: manufacturing licence or import licence.
Get a free CDSCO licence check
Tell us what you do (sell, import or manufacture), the devices and their class if known, and your city. We will tell you which licence you need, the forms, fees and documents.
Frequently asked questions
How many classes of medical devices are there in India?
How do I find my device’s class?
Are IVDs classified differently?
Does the class affect the fee?
Need a medical device licence?
Talk to the Medasus regulatory team in Bengaluru. We prepare applications, documents and quality systems for MD-42, import and manufacturing licences.
Last reviewed on 2 November 2026 against: CDSCO: Medical Devices Rules, 2017 and notifications; CDSCO online medical device portal: fee schedule (Second Schedule); Drugs Control Department, Karnataka. Medasus Healthcare Pvt Ltd is a private consultancy that helps establishments prepare and file applications. Licences and approvals are granted only by the respective government departments; Medasus cannot guarantee approval or timelines. Rules and fees change, so always check the official source before applying.
