The costs and time required for Class C medical device registration with CDSCO in India can vary based on several factors, including the complexity of the device and the completeness of the application. Here’s a general overview:

Costs

1. Application Fees:

   • Class C Device Registration Fee: Typically ranges from ₹50,000 to ₹1,00,000 or more. The exact fee depends on the type and complexity of the device. This fee is payable online through the SUGAM portal.

2. Additional Costs:

   • Consultancy Fees: If you hire a regulatory consultant, fees can vary widely based on the consultant’s experience and the scope of services.
   • Inspection Costs: If an on-site inspection is required, there may be additional costs associated with travel and logistics.
   • Testing and Clinical Trials: Costs for clinical trials, testing, and certification can vary based on the device and required studies.

Time Required

1. Application Preparation:

   • Document Compilation: Preparing the necessary documentation can take several weeks to months, depending on the availability of data and the complexity of the device.

2. Submission to Approval:

   • Initial Review: CDSCO typically takes around 3-6 months to perform an initial review of the application.
   • Inspection and Testing: If required, inspections and testing can add an additional 2-3 months to the process.
   • Final Approval: After review and any necessary inspections, final approval may take another 1-2 months.

3. Overall Timeline:

   • Total Time: From submission to final approval, the process usually takes between 6 to 12 months. However, this can vary based on the specific circumstances and any additional requirements.

Key Factors Affecting Time and Cost

• Completeness of Application: Well-prepared and complete applications are processed faster.
• Device Complexity: More complex devices may require additional review time and higher costs.
• Regulatory Changes: Any changes in regulations or additional requirements can affect processing times and costs.

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