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Form MD-14 — Import Licence (Class B / C / D)

What is Form MD-14?​

Form MD-14 is the import licence issued by CDSCO under Rule 10 of the Medical Devices Rules 2017 for Class B, C, and D medical devices. It authorises the IAR to import and distribute the specified device in India.

Key features​

  • Issued by the Central Licensing Authority (DCGI / CDSCO);
  • Linked to a specific device, manufacturer, and IAR;
  • Typically valid for 5 years from the date of grant;
  • Renewable before expiry.

Step-by-step application process​

  1. Create SUGAM account — register the IAR and foreign manufacturer on sugam.cdsco.gov.in;
  2. Compile documents — FSC, CoC, technical file, test reports, labelling, IAR appointment;
  3. Submit application online — complete Form MD-14 on SUGAM and upload all documents;
  4. Pay fees — via SUGAM payment gateway (fees vary by device class);
  5. CDSCO review — CDSCO may raise queries (deficiency letters) within the review period;
  6. Respond to queries — within the specified response period;
  7. Grant of licence — Form MD-14 issued electronically via SUGAM.

Typical timelines​

Device classTarget CDSCO review time
Class B30–45 working days (indicative)
Class C45–60 working days (indicative)
Class D (new device)90+ working days (indicative)

Note: these are indicative and subject to query cycles and CDSCO workload.

Conditions of licence​

The licence is subject to conditions including: maintenance of GMP by the manufacturer, label compliance, adverse event reporting, and notification of changes.

Official source: Medical Devices Rules 2017, Rule 10 and Form MD-14; SUGAM portal