All medical devices in India are regulated under the Medical Devices Rules, 2017. Devices are classified by risk into Class A, B, C and D. Manufacturing licences for Class A and B are issued by the State Licensing Authority, while Class C and D manufacturing and all import licences are issued by CDSCO. Applicants must follow quality management system requirements and apply online.
Risk classification
| Class | Risk | Example |
|---|---|---|
| A | Low | Bandages, tongue depressors |
| B | Low-moderate | Thermometers, needles |
| C | Moderate-high | Ventilators, implants |
| D | High | Heart valves |
Licences
- Manufacturing licence for Class A and B from the state
- Manufacturing licence for Class C and D from CDSCO
- Import licence from CDSCO
- Test licence for samples
Process
- Classify the device.
- Prepare device master file and plant master file.
- Implement QMS.
- Apply online with fees.
- Audit or inspection and grant.
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Labelling rules, adverse event reporting, and periodic compliance apply.
Frequently asked questions
Do all medical devices need a licence now?
Yes. The licensing regime has been extended to all classes of medical devices under the rules.
Who can apply for an import licence?
An Indian entity holding a wholesale licence, often as the authorised agent of the foreign manufacturer.
Is ISO 13485 mandatory?
The rules prescribe QMS requirements in line with ISO 13485; certification helps demonstrate compliance.
How long does CDSCO licensing take?
It varies by class and completeness, from weeks to several months.
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