The costs and timeframes for CDSCO registration of Class A medical devices in India are as follows:

Costs:

1. Application Fees:

   • Class A Devices: The registration fee is relatively lower compared to higher-class devices. Typically, it ranges from ₹10,000 to ₹25,000, depending on the type and quantity of devices.

2. Additional Costs:

   • Consulting Fees: If you hire a consultant to assist with the registration process, their fees will vary based on the complexity and scope of their services.
   • Testing and Certification Fees: Costs for testing and obtaining certifications, if required, are additional.

Timeframes:

1. Application Processing:

   • Initial Review: The preliminary review of the application and documents generally takes about 30 to 60 days.
   • Approval Time: For Class A devices, the overall approval time is usually around 3 to 6 months, depending on the completeness of the application and the workload of CDSCO.

2. Possible Delays:

   • Incomplete Documentation: Delays may occur if there are any discrepancies or missing documents, which could extend the processing time.
   • Additional Information Requests: If CDSCO requests further information or clarification, this can also impact the timeline.

Summary:

• Fees: Approximately ₹10,000 to ₹25,000
• Processing Time: Typically 3 to 6 months