In the context of medical device licensing in India, a post-submission request refers to any communication or additional documentation submitted to CDSCO after the initial application for a license or endorsement has been submitted but before a final decision has been made.

Reasons for Post-Submission Requests

• Clarifications: CDSCO may request additional information or clarification regarding certain aspects of the application, such as product specifications, manufacturing processes, or quality management systems.
• Additional Documentation: Applicants may need to submit additional documents that were not included in the original application, such as updated test reports, certificates, or revised product labels.
• Responses to Queries: Applicants may need to respond to specific queries raised by CDSCO during the review process.
• Addressing Deficiencies: If any deficiencies are identified in the application during the review process, applicants will be given an opportunity to address them through a post-submission request.

How to Submit Post-Submission Requests

Post-submission requests can be submitted online through the SUGAM portal, the same platform used for the initial application submission. It is important to follow the specific instructions and timelines provided by CDSCO for submitting post-submission requests.

Important Considerations

• Timeliness: Timely submission of post-submission requests is crucial to avoid delays in the licensing process.
• Completeness: Ensure that all requested information and documentation are provided in a clear and concise manner.
• Accuracy: Double-check all information and documentation for accuracy before submission.
• Professional Guidance: If you are unsure about how to respond to a post-submission request, seek professional guidance from a regulatory consultant or expert.