Cost and Time Required for CDSCO Registration of Class D Medical Devices in India

1. Cost:

The cost for CDSCO registration can vary based on several factors, including the type of device, its classification, and the specific requirements of the registration process. As of recent updates, the fees for Class D medical devices generally include:

• 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.
• Inspection Fees: If an inspection of the manufacturing site is required, additional fees may apply.
• Renewal Fees: Fees for renewing registration, which are required periodically to maintain the certification.

Exact figures for the fees can be obtained from the CDSCO SUGAM portal or by contacting CDSCO directly. It's advisable to check the latest fee schedule on the CDSCO website or consult with a regulatory expert for accurate cost estimates.

2. Time Required:

The time required for CDSCO registration of Class D medical devices can vary based on several factors:

• Application Preparation: Preparing the application and compiling the necessary documentation can take several weeks to months, depending on the complexity of the device and the availability of required documents.
• Review Process: The review process by CDSCO generally takes between 3 to 6 months, but this can vary based on the workload of CDSCO, the completeness of the submission, and whether additional information or clarification is required.
• Inspection (if applicable): If an inspection of the manufacturing site is required, this may add additional time to the overall process, potentially extending the timeline by a few weeks to months.
• Approval and Issuance: Once the review and inspection (if applicable) are completed, the issuance of the registration certificate may take additional time.

Overall Timeline:

• Typical Duration: The entire process from submission to receiving the registration certificate can range from 6 to 12 months. This timeline can be affected by the complexity of the device, the completeness of the application, and the efficiency of the review process.

Key Considerations:

• Planning Ahead: Allow sufficient time for preparation and anticipate potential delays in the review or inspection process.
• Consultation: Engaging with regulatory experts or consultants can help streamline the process and ensure timely submission and approval.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn