The processing time for Class C medical device registration with the Central Drugs Standard Control Organization (CDSCO) in India can vary based on several factors. However, the general timeline is as follows:

1. Application Review

• Initial Processing: Upon submission of your application through the SUGAM portal, CDSCO typically acknowledges receipt and begins the initial review. This can take about 2 to 4 weeks.

2. Technical Evaluation

• Detailed Review: The technical evaluation of the application, which includes reviewing the technical documentation, clinical data, risk management file, and other related documents, generally takes 2 to 3 months. The exact duration can depend on the complexity of the device and the completeness of the application.

3. Facility Inspection

• Inspection Schedule: If an inspection of the manufacturing facility is required, it can add additional time. The scheduling and conducting of the inspection can take approximately 1 to 2 months, depending on the availability of CDSCO inspectors and the readiness of the facility.

4. Additional Information Requests

• Queries and Clarifications: If CDSCO requests additional information or clarifications, the processing time can be extended. The time to address these queries and resubmit information can vary, but typically, each round of queries might add 1 to 2 months to the process.

5. Final Decision

• Approval: After the technical evaluation and any required inspections, CDSCO will make a final decision on the registration. The final review and approval process can take an additional 1 to 2 months.

Overall Timeline

• Estimated Total Time: Considering the above stages, the total processing time for Class C medical device registration with CDSCO is generally 6 to 9 months. This timeline can vary based on the complexity of the device, the completeness of the application, and any additional requirements or delays.

Factors Affecting Processing Time

1. Completeness of Application: A complete and accurate application with all required documents can expedite the process.
2. Complexity of Device: More complex devices or those requiring extensive clinical data may take longer for review.
3. Inspection Requirements: The need for an on-site inspection can add to the timeline.
4. Regulatory Changes: Changes in regulations or CDSCO procedures can impact processing times.

Tips to Expedite Processing

• Ensure Accuracy: Double-check that all documentation is complete and accurate before submission.
• Respond Promptly: Address any queries or requests for additional information from CDSCO quickly.
• Consult Experts: Consider working with regulatory consultants to ensure compliance and help navigate the process efficiently.

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