Import licence
Importing medical devices or IVD kits into India needs an MD-15 import licence from CDSCO.
- 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
Import licence basics
To import medical devices for sale or distribution, the foreign manufacturer’s authorised agent in India applies to the Central Licensing Authority (CDSCO) in Form MD-14. The licence is issued in Form MD-15. Separate licences exist for import for test, evaluation, demonstration or training.
Official fees
| Import licence fee (Second Schedule, rule 34) | Per overseas site | Per distinct device |
|---|---|---|
| Class A (other than IVD) | US$ 1,000 | US$ 50 |
| Class B (other than IVD) | US$ 2,000 | US$ 1,000 |
| Class C or D (other than IVD) | US$ 3,000 | US$ 1,500 |
| Class A or B IVD | US$ 1,000 | US$ 10 |
| Class C or D IVD | US$ 3,000 | US$ 500 |
| Inspection of an overseas manufacturing site (rule 35) | US$ 6,000 | |
| Import licence for test, evaluation, demonstration or training (rule 40) | US$ 100 per distinct device | |
A retention fee (rule 37) is payable at the same site and device rates to keep the licence in force.
Documents usually needed
- Power of attorney from the foreign manufacturer, authorising the Indian agent
- Sale licence or MD-42 registration of the Indian agent, where applicable
- Free sale certificate from the country of origin and regulatory approvals in reference countries
- ISO 13485 or equivalent quality management certificate of the overseas site
- Device master file and plant master file
- Labels, instructions for use and the device class with justification
- Test reports and essential principles checklist as required
CDSCO may inspect the overseas manufacturing site (fee US$ 6,000). Devices without a predicate need permission under rule 63 first.
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
Who can apply for a medical device import licence?
Which form is used to import medical devices?
What is the import licence fee for Class B devices?
Can a new device without a predicate be imported?
Is the import licence valid for life?
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.
