Medical Device Import License in India — MD-14 / MD-15
Get your medical device import license (MD-14/MD-15) from CDSCO. DK Reg Compliance prepares Device Master Files, Plant Master Files, and manages full SUGAM submission.
- Businesses operating or planning to open in India
- Entities needing fast-track regulatory approval without delay
- First-time applicants requiring complete documentation guidance
Connect with our senior regulatory experts in 15 mins.
Overview & Local Scope
Fast-Track Medical Device Import License India in India
Get your medical device import license (MD-14/MD-15) from CDSCO. DK Reg Compliance prepares Device Master Files, Plant Master Files, and manages full SUGAM submission.
Need help with your application in India?
Our local experts are ready to guide you through the process.
Businesses operating or planning to open in India
Entities needing fast-track regulatory approval without delay
First-time applicants requiring complete documentation guidance
What Is MD-14 and MD-15?
Form MD-14 is the application submitted to CDSCO’s Central Licensing Authority for an import license for medical devices. Form MD-15 is the import license issued upon approval — the legal document that allows foreign-manufactured medical devices to be imported and sold in India. Every Class B, C, and D medical device from outside India requires a valid MD-15 before it can enter Indian customs.
Who Needs This?
- Foreign medical device manufacturers entering the Indian market
- Indian importers acting as distributors for international brands
- Indian Authorised Agents (IAA) filing on behalf of overseas manufacturers
- Importers seeking multi-product registration under a single base license
Documents Required for MD-14 Application
- Device Master File (DMF): technical documentation covering device description, intended use, materials, manufacturing process, and clinical performance data
- Plant Master File (PMF): documentation of the manufacturing facility’s GMP systems
- Free Sale Certificate (FSC): issued by the regulatory authority of the country of manufacture
- ISO 13485:2016 certification of the manufacturing site
- Authorization letter from the foreign manufacturer to the Indian Authorised Agent
- Test reports from accredited laboratory (as applicable for device class)
- SUGAM portal registration for the IAA
License Validity and Renewal
MD-15 import licenses are valid for 5 years. Critically, any products added via endorsement during the 5-year period expire at the same time as the base license — not from the date of endorsement. DK Reg tracks your license and endorsement expiry dates and initiates renewal well in advance.
Step-by-step process
How our India registration works
Assess your business model and India regulatory classification.
Prepare and verify applicant documents and premises layout.
Submit application to the state/zonal authority covering India and track queries.
Receive final license delivery with ongoing compliance alerts.
Documents required
Filing checklist for India
- Identity and address proof of the applicant/directors
- Premises ownership or valid rental agreement in India
- Layout plan and site dimensions of the facility
- Business constitution documents (COI/Partnership Deed)
- Affidavits and declarations as required by India authority
Verified Support in India
Whether you are located in the business center of India or surrounding industrial corridors, our consultants manage state and zonal submissions directly.
Guaranteed Benefits
Medical Device Import License India in Nearby Cities
Explore our fast-track regulatory consultancy and compliance assistance in nearby locations:
Other Compliance Services in India
Complete statutory and license solutions provided by our regulatory consultants:
Find your question below or submit your inquiry for quick assistance.
Ready to proceed?