Medical Device Licence (CDSCO)
Manufacturing or import licence for medical devices under the Medical Devices Rules.
Reviewed by CA Hitendra Pal Singh· company law, tax and complianceLast reviewed
Every medical device is now risk-classed A to D and licensed under the Medical Devices Rules, 2017. Class A and B are licensed by the state licensing authority, C and D by CDSCO, and all imports go through CDSCO. Low-risk Class A devices need only a registration certificate. The device file, the QMS evidence and the classification are where applications fail.
What is included
- Device classification
- Plant master file and device master file preparation
- ISO 13485 and QMS coordination
- Application on the SUGAM portal
- Inspection or audit coordination
- Licence certificate
What we will need from you
- Certificate of Incorporation and PAN
- Site and premises documents
- ISO 13485 certificate or QMS evidence
- Device technical file, labels and instructions for use
- Free-sale certificate for imports
- Wholesale drug licence where applicable
How long it takes
Typically 60–120 working days by class.
Timelines are typical, not guaranteed. Government processing times vary, and a query from the officer adds to them. We will tell you where yours stands.
Common questions
We sell thermometers — do we need a licence?
A non-sterile, non-measuring Class A device needs only registration; a measuring device moves to a licence. We classify before quoting.