CDSCO Medical Device Licence
Import and manufacturing licences for medical devices under the Medical Devices Rules, 2017.
Quick answer
Medical devices in India need a licence under the Medical Devices Rules, 2017. Importers apply to CDSCO on Form MD-14 for an import licence in Form MD-15; manufacturers apply for a manufacturing licence, from the State Licensing Authority for Class A and B devices and from CDSCO for Class C and D. CorpBridge handles medical device licensing from ₹29,999.
| Professional fee | ₹29,999 + 18% GST |
|---|---|
| Government charges | CDSCO fees, which depend on device class and number of products |
| Time taken | Typically 3–9 months depending on class |
| Form / portal | MD-14 / MD-15 (import), MD-3 / MD-7 (manufacture) |
| Documents | 4 items (listed below) |
| Done | 100% online |
What is CDSCO Medical Device Licence?
All medical devices are now regulated by risk class (A low to D high). The class decides who grants the licence, which documents are needed and how long approval takes.
We classify your device, prepare the device master file and plant master file, file on the online portal and handle queries. If your device is also patentable, see our medical device patent guide.
What's included in our CDSCO Medical Device Licence service?
- Device risk classification
- Device master file and plant master file preparation
- Application on the online portal (import or manufacture)
- Query replies and audit support
- Post-approval compliance checklist
What documents are required for CDSCO Medical Device Licence?
- Device details, intended use and labels
- Free sale certificate and ISO 13485 certificate (for imports)
- Manufacturer and Indian agent details
- Test reports and clinical data where needed
What is the process for CDSCO Medical Device Licence?
Classify
We confirm the device class and route.
Prepare
Master files and documents are compiled.
File
Application filed with CDSCO or the State authority.
Approve
Queries answered until the licence is granted.
How much does CDSCO Medical Device Licence cost?
| Component | Amount | Paid to |
|---|---|---|
| CorpBridge professional fee | ₹29,999 | CorpBridge |
| GST on professional fee | ₹5,400 | Government (via CorpBridge) |
| Government fee / stamp duty | CDSCO fees, which depend on device class and number of products | Government, at actuals |
Your expert confirms the exact government charges for your case before you pay. Build a full package estimate →
Frequently asked questions about CDSCO Medical Device Licence
Which form is used to import medical devices into India?
The application is made on Form MD-14, and the import licence is granted on Form MD-15 by CDSCO.
What is the cost of CDSCO Medical Device Licence?
CorpBridge's professional fee is ₹29,999, exclusive of 18% GST, plus CDSCO fees, which depend on device class and number of products. The exact government charges are confirmed before you pay.
How long does CDSCO Medical Device Licence take?
Typically 3–9 months depending on class, assuming documents are complete and the authority raises no queries.
What documents are required for CDSCO Medical Device Licence?
Device details, intended use and labels; Free sale certificate and ISO 13485 certificate (for imports); Manufacturer and Indian agent details; Test reports and clinical data where needed.
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