The time required to obtain Class C medical device registration with CDSCO in India can vary based on several factors, including the complexity of the device, the completeness of the application, and the efficiency of the review process. Generally, the entire process can take several months to a year or more. Here’s a breakdown of the typical timeline:

1. Pre-Application Preparation

• Duration: 1-3 months
• Activities:
  • Gathering technical documentation
  • Securing ISO 13485 and GMP certifications
  • Conducting clinical evaluations and preparing reports

2. Application Submission

• Duration: 1-2 weeks
• Activities:
  • Registering on the CDSCO SUGAM portal
  • Completing and submitting the application form
  • Uploading required documents
  • Paying application fees

3. Initial Review and Processing

• Duration: 1-2 months
• Activities:
  • CDSCO’s initial review of submitted documents
  • Request for additional information or clarifications

4. Technical Evaluation

• Duration: 2-4 months
• Activities:
  • Detailed examination of technical documentation and clinical data
  • Possible consultation with external experts

5. Facility Inspection (if applicable)

• Duration: 1-2 months
• Activities:
  • Scheduling and conducting the inspection
  • Addressing any findings from the inspection

6. Decision and Certification

• Duration: 1-2 months
• Activities:
  • Evaluation of all findings
  • Issuance of the registration certificate if approved

Total Estimated Time

• Overall Duration: Approximately 6 to 12 months

Factors Affecting the Timeline

1. Completeness of Application: A well-prepared and complete application can expedite the review process.
2. Complexity of the Device: Devices with complex technology or higher risks may require more extensive evaluation.
3. CDSCO Workload: The review timeline can vary depending on CDSCO’s current workload and backlog.
4. Inspection Scheduling: Availability of inspectors and scheduling of on-site inspections can impact the timeline.

Tips for Expediting the Process

• Thorough Preparation: Ensure all documentation is complete, accurate, and up-to-date before submission.
• Responsive Communication: Quickly address any queries or additional information requests from CDSCO.
• Proactive Follow-Up: Regularly check the status of your application on the SUGAM portal and follow up as needed.