The cost and time required for CDSCO registration of Class B medical devices can vary based on several factors. Here's a general overview:

Cost

1. Application Fee: The application fee for CDSCO registration of Class B medical devices typically ranges from ₹10,000 to ₹25,000. The exact fee can depend on the type of device and the nature of the application.

2. Additional Costs: There might be additional costs for document preparation, quality management system compliance, facility inspection (if required), and consultancy fees if you hire a regulatory expert.

Time Required

1. Documentation Preparation: Preparing the necessary documentation can take several weeks to months, depending on the complexity of the device and the availability of clinical data.

2. Application Processing: Once submitted, the review process by CDSCO generally takes about 3 to 6 months. This timeframe can vary based on the completeness of the application, the need for additional information, or the complexity of the device.

3. Inspection (if required): If a facility inspection is needed, it can add additional time to the overall process. Inspections might take a few weeks to schedule and complete.

4. Approval: After the review and inspection (if applicable), receiving the registration certificate typically takes a few additional weeks.

Summary

• Cost: ₹10,000 to ₹25,000 for the application fee, plus potential additional costs.
• Time: Approximately 3 to 6 months, depending on various factors including the completeness of the application and inspection requirements.