Compile Documents: Gather all necessary documents and information required for the application. This includes technical, clinical, and manufacturing details.

Online Application: Submit your application through the CDSCO SUGAM portal, the official online platform for medical device registration in India.

Application Fee: Fees vary depending on the specific device and its classification. Class D devices typically incur higher fees due to their high-risk status.

Device Description: Detailed information about the device, including its intended use, design, and technology.

Understand Classification: Ensure your device is classified as Class D, which is high-risk, including critical devices like implantables.

Overview: The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for medical devices in India. Class D medical devices are those considered high-risk, including implantable devices or those critical to life support. Registration with CDSCO ensures compliance with the Drugs and Cosmetics Act and Rules, ensuring safety and efficacy for users in India.

Prepare Documentation: Gather required documents, including product details, clinical data, manufacturing information, and quality management system certificates (ISO 13485).

The time required to obtain Class C medical device registration with CDSCO in India can vary based on several factors, including the complexity of the device, the completeness of the application, and the efficiency of the review process. Generally, the entire process can take several months to a year or more.