Obtaining CDSCO registration for Class D medical devices typically takes between 6 to 12 months. The duration can vary based on several factors, including the completeness of the application, the complexity of the device, and the efficiency of the review process. Here is a breakdown of the typical timeline:

1. Pre-Application Preparations:

• Timeframe: 1-3 months
• Activities: Preparing documentation such as clinical data, technical details, and quality management system information.

2. Application Submission:

• Timeframe: 1-2 weeks
• Activities: Registering on the SUGAM portal, completing the application form, and submitting the required documents and fees.

3. Initial Review:

• Timeframe: 1-2 weeks
• Activities: CDSCO performs an initial review to ensure that all required documents are submitted and complete.

4. Detailed Evaluation:

• Timeframe: 2-6 months
• Activities: Comprehensive review of technical documentation, clinical data, and risk management reports. This stage may include:
  • Technical Review
  • Clinical Review
  • Requests for Additional Information: If CDSCO requests more details, this may extend the review period.

5. Inspection (if applicable):

• Timeframe: 1-2 months
• Activities: CDSCO may conduct an inspection of the manufacturing facility to verify compliance with regulatory standards.

6. Approval and Issuance:

• Timeframe: 1 month
• Activities: Once the review and inspection (if applicable) are completed, CDSCO issues the registration certificate.

Factors Affecting the Timeline:

• Application Completeness: Submitting a complete and accurate application can help expedite the process.
• Device Complexity: Higher complexity devices may require more extensive review.
• Regulatory Requests: Additional information or clarifications requested by CDSCO can extend the timeline.
• Inspection Scheduling: Timing for facility inspections can impact the overall process.