SUGAM Portal โ Submission Process
What is SUGAM?โ
SUGAM (Hindi: เคธเฅเคเคฎ, meaning "easy" or "accessible") is CDSCO's online portal at sugam.cdsco.gov.in for submitting and tracking all CDSCO-level applications, including import licences, manufacturing licences, clinical investigation permissions, and vigilance reports.
Before you startโ
- Register your IAR organisation on SUGAM;
- Register the foreign manufacturer on SUGAM;
- Prepare all documents in acceptable formats (PDF, size limits apply);
- Confirm the applicable form (MD-14 for Class B/C/D; MD-15 for Class A).
Submission stepsโ
- Login to your SUGAM account as the IAR;
- Select "New Application" โ "Import Licence" โ choose device class;
- Fill Form MD-14 โ enter device details, manufacturer details, IAR details;
- Upload documents โ FSC, CoC, technical file, test reports, labelling, IAR appointment letter;
- Preview and validate โ check for form errors before submission;
- Pay fee โ SUGAM will direct you to the payment gateway (NEFT/RTGS/online);
- Submit โ receive an application number (token) for tracking;
- Track status โ log in to SUGAM to monitor application status, query letters, and approvals.
Responding to deficiency queriesโ
If CDSCO raises a deficiency letter (DL), you will be notified via SUGAM and email. Respond by uploading the additional documents or clarifications within the specified deadline. Failure to respond within the deadline may result in rejection.
After approvalโ
Upon approval, the Form MD-14 licence is issued electronically via SUGAM. Download and retain the licence document.