CDSCO Application Status: What Different SUGAM Portal Statuses Mean

Navigating regulatory approvals for medical devices in India requires a clear understanding of the Central Drugs Standard Control Organisation (CDSCO) processes under the Medical Devices Rules (MDR), 2017. The SUGAM portal (System for Unmanned Gateways Approval of Manufacturers), accessible at cdscoonline.gov.in, serves as the primary e-governance platform for submitting and tracking applications related to drugs, cosmetics, medical devices, and clinical trials. For medical device manufacturers, importers, and Indian Authorized Agents, applications such as Form MD-14 (import licence leading to MD-15), manufacturing licences (MD-7/MD-9 or MD-3/MD-5), test licences, and related permissions are processed online through this system or aligned portals.

Tracking application status on the SUGAM portal is essential for compliance, timely responses, and avoiding delays or rejections. Applicants log in to their dashboard, navigate to Submitted Applications (or equivalent sections under Application Submission), and check the Status column for each file. Below is a clear explanation of the key statuses commonly displayed, based on official CDSCO guidance and portal functionality, along with their practical implications under MDR 2017.

Saved as Draft
This status appears when an applicant has begun filling an application form but has not yet submitted it to CDSCO. The incomplete file remains in the Saved Applications section. At this stage, users can edit details, upload or replace documents, and complete mandatory checklists. No review by CDSCO has started. Applicants should ensure all technical documentation required under MDR 2017 (device description, intended use, risk classification as per the First Schedule, essential principles of safety and performance, quality management system evidence such as ISO 13485, labelling, and plant master file or device master file as applicable) is ready before final submission. Leaving applications in draft for extended periods risks outdated information or missed regulatory updates.

Submitted to CDSCO / Application Submitted
Once the applicant completes the form, uploads supporting documents, pays the prescribed fees (as per the Second Schedule of MDR 2017), and submits the application, the status changes to Submitted to CDSCO. This confirms that the application has entered the CDSCO workflow. It is typically awaiting initial screening or allocation to a reviewing officer. No queries have been raised yet. Regular monitoring is advisable, as processing timelines vary by device class (Class A low-risk devices generally move faster than Class C or D higher-risk devices) and completeness of the dossier. Foreign manufacturers must act through a registered Indian Authorized Agent, who handles the portal interactions.

Under Review / Application In Process
This indicates that CDSCO officials have begun examining the application. Reviewers assess compliance with MDR 2017 requirements, including risk classification, technical documentation, clinical evaluation data (where required), and manufacturing or import site details. For higher-risk devices, this stage may involve additional scrutiny or coordination with Notified Bodies for audits in certain manufacturing licence cases. The application remains active, and no formal deficiencies have been communicated. Patience is needed, but applicants should keep contact details and email notifications enabled for any updates.

Query Raised
One of the most critical statuses is Query Raised. CDSCO has identified deficiencies, missing information, clarifications needed, or inconsistencies in the submitted documents or checklist. Common reasons include incomplete technical files, unclear intended use statements, expired certificates, labelling issues, or gaps in risk analysis.

According to the portal’s guidance, when the status shows Query Raised, the applicant must go to the action column, select View/Modify checklist (or Respond to Query), and upload revised documents or responses against the specific items. Timely action is essential. Recent CDSCO public notices (including those addressing long-pending applications) emphasize a structured reminder process: if responses are not submitted, reminders are issued at intervals (typically 30 days). Failure to respond after three reminders can lead to a final disposal notice, permanent rejection of the application, and forfeiture of fees. Applications pending for extended periods (such as more than two years) face heightened risk of rejection under these measures.

Under MDR 2017, a complete and accurate response helps maintain the application’s place in the queue. Extensions may sometimes be requested with justification, but proactive communication through the portal and registered email is the safest approach. Indian Authorized Agents play a key role in monitoring and coordinating responses for overseas manufacturers.

Verified by CDSCO / Approved
This positive status means CDSCO officials have reviewed the application (and any query responses) and found it satisfactory. For historical data or certain permissions, “Verified by CDSCO” confirms approval of submitted details. For licence applications, it typically precedes or coincides with the formal grant of the relevant Form (for example, MD-15 for import licences). Once approved, the licence or permission becomes available for download from the portal. Under current MDR 2017 provisions, many licences are perpetual subject to payment of retention fees every five years and ongoing compliance (including post-market surveillance and adverse event reporting). Applicants should download and retain official copies and ensure any site or product changes are notified as required.

Rejected by CDSCO / Rejected
Rejection occurs when the application fails to meet regulatory requirements even after queries, or when applicants do not respond within stipulated timelines (including the reminder process for long-pending files). Reasons may include fundamental non-compliance with MDR 2017 classification rules, inadequate safety and performance data, or unresolved deficiencies. Fees are generally not refunded. A rejection notice is communicated, and the applicant may need to address the issues and submit a fresh application if proceeding. Careful preparation of the initial dossier significantly reduces this risk.

Closed
In some contexts, Closed indicates that the application cycle has concluded, either after approval and licence issuance or following formal disposal/rejection. It may also appear for certain post-approval or administrative files once no further action is pending.

How MDR Consultants Can Help

Understanding a portal status is only one part of successful medical-device regulatory management.

The more important question is:

What action should be taken next?

At MDR Consultants, we support medical-device companies with regulatory activities including:

✅ Medical-device regulatory strategy

✅ CDSCO/SUGAM application support

✅ Import licence applications

✅ Manufacturing licence applications

✅ Device classification assessment

✅ Technical documentation and dossier preparation

✅ QMS and ISO 13485 support

✅ CDSCO query response management

✅ Regulatory gap assessments

✅ Application tracking and monitoring

✅ Audit and inspection readiness

Our objective is not simply to help clients submit an application.

It is to help them build a regulatory pathway that supports efficient approval, continued compliance and successful market access in India.

Final Takeaway

The CDSCO SUGAM portal should not be viewed simply as a place to submit an application.It is an important part of the medical-device regulatory lifecycle.Understanding what each application status generally means—and knowing what action is required at each stage—can help manufacturers and importers avoid preventable delays.

Last Updated : 26 Aug 2026