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.
- Fast-track application drafting & authority liaisoning
- Guaranteed compliance with CDSCO/FSSAI/State guidelines
- 100% turnkey documentation support from start to approval
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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.
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Other Services
Get your drug license for retail, wholesale, or manufacturing with DK Reg Compliance — India’s trusted drug license consultant. Expert guidance, fast approvals, pan-India service.
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Get your drug manufacturing license for tablets, capsules, injectables, or Ayurvedic formulations. DK Reg Compliance handles GMP compliance, Form 25 filing, and state FDA coordination.
Expert CDSCO registration support for medical devices, drugs, IVDs, and cosmetics. DK Reg Compliance handles classification, SUGAM filing, and query responses — free assessment call.
Medical device registration in India — Class A, B, C, D classification, CDSCO filing, MD-14/MD-15 import licenses, and IVD registration. Expert support from DK Reg Compliance.
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