The time cycle for CDSCO registration of Class D medical devices can vary based on several factors, including the completeness of the application, the complexity of the device, and the efficiency of the review process. However, here is a general timeline and breakdown of the stages involved:

1. Pre-Application Preparations:

• Timeframe: 1-3 months
• Activities: Preparing all required documentation, including 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 the application is complete and all documents are correctly submitted.

4. Detailed Evaluation:

• Timeframe: 2-6 months
• Activities: Detailed assessment of technical documentation, clinical data, risk management reports, and other relevant information. This period may include:
  • Technical Review: Evaluating the device’s design, efficacy, and safety.
  • Clinical Review: Analyzing clinical data and trial results.
  • Requests for Additional Information: If CDSCO requires more details or clarification, the review period may be extended.

5. Inspection (if applicable):

• Timeframe: 1-2 months
• Activities: CDSCO may conduct an inspection of the manufacturing facility. Scheduling and conducting the inspection can add time to the overall process.

6. Approval and Issuance:

• Timeframe: 1 month
• Activities: Once the review is complete and all requirements are met, CDSCO issues the registration certificate.

7. Total Time Cycle:

• Estimated Total: 6-12 months
• This estimate includes all stages from preparation to receiving the registration certificate. The actual time can vary based on the specifics of the device and any additional requirements or delays.

Factors Affecting the Time Cycle:

• Completeness of Application: Submitting a complete and accurate application can help avoid delays.
• Complexity of the Device: High-risk devices may require more extensive review.
• Regulatory Requests: Additional information or corrections requested by CDSCO can extend the timeline.
• Inspection Schedule: Timing for facility inspections can impact the overall process.

Tips for Expediting the Process:

• Prepare Thoroughly: Ensure all documentation is accurate and complete.
• Respond Promptly: Address any requests for additional information quickly.
• Consult Experts: Engage with regulatory consultants if needed to navigate complex requirements.

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