In the dynamic landscape of medical device regulations in India, any alteration to the intended use or indication of a device is a significant change that warrants attention and notification to the Central Drugs Standard Control Organization (CDSCO). Whether you are dealing with Import Licenses or Manufacturing Licenses, understanding the impact of changes in the intended use is crucial for regulatory compliance.

Key Considerations for Change in Intended Use/Indication:

Licenses in India, be it Import Licenses or Manufacturing Licenses, are intricately tied to various factors such as manufacturing sites, device names, intended use, material of construction, shelf life, and more. A notable change in the intended use or indication of a device is considered a major alteration under the Sixth Schedule of Medical Device Rules, 2017.

Post-Approval Change Notification Process:

In the event of a change in intended use or indication, manufacturers must initiate a post-approval change notification to CDSCO. This process involves the submission of specific documents for review. The essential documents include:

• Covering Letter: Clearly outlining the purpose of the notification.
• Justification/Rationale: Providing a comprehensive explanation for the proposed changes.
• Old Import License: Documenting the previous license for reference.
• Updated Package Inserts: Reflecting the extended indication.
• Comparison Documents: Contrasting the old and new package inserts in terms of indication.
• Reference to Predicate: Establishing a connection to a similar device for the proposed intended use.
• Undertaking from Manufacturer: Confirming no changes affecting the device’s quality including manufacturing process, equipment or testing, design, approved shelf life, material of construction, which shall affect the quality of the device
• Approval from Country of Origin: Obtaining approval for the proposed indication from the national regulatory authority.
• List of Approved Countries: Enumerating countries where the proposed change has been approved.
• Clinical Evidence: Presenting clinical evidence supporting the proposed indication.

CDSCO Review and Approval:

Upon submission of the documents, CDSCO undertakes a thorough review process. Within 60 days from the date of submission, CDSCO issues either an approval or rejection. If no communication is received within this timeframe, the change can be considered approved. Following approval, importers can proceed with importing products with the updated intended use into India.

How 8C Healthcare Can Assist:

Understanding the intricacies of CDSCO notifications and ensuring compliance with regulatory requirements can be a complex task. At 8C Healthcare, we specialize in facilitating the regulatory journey for medical device companies. If you are applying for an import license with CDSCO and intend to file a post-approval change notification regarding modifications to the device’s indication or intended use, do not hesitate to contact us at contact@8chealthcare.com. Our team is here to guide you through the process and ensure a smooth transition in compliance with Indian medical device regulations. Your success in the Indian market is our priority.