The timeframe to receive CDSCO registration for Class A 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. Generally, the process can be broken down into the following stages:

1. Preparation Time:

• Document Preparation: Gathering and preparing the necessary documentation, such as technical files, quality management system certification, and manufacturing licenses, can take several weeks to a few months depending on the complexity of the device and the availability of information.
• Quality Management System Certification: Obtaining ISO 13485 or an equivalent certification, if not already in place, can also add time.

2. Application Submission:

• SUGAM Portal Submission: Submitting the application and required documents through the CDSCO SUGAM portal is a relatively quick process and typically takes a few hours to a day.

3. Initial Review:

• Document Verification: The initial review of the application by CDSCO to check for completeness and correctness usually takes around 1-2 weeks.

4. Detailed Evaluation:

• Technical Review: The detailed review of technical documentation, safety and performance data, and quality management system compliance generally takes about 4-6 weeks. This can vary based on the device's complexity and the thoroughness of the documentation.

5. Response to Queries:

• Additional Information Requests: If CDSCO requests additional information or clarifications, the time to respond will depend on how quickly you can provide the requested details. This can add a few weeks to the overall timeframe.

6. Facility Inspection (if required):

• Inspection Scheduling: If a facility inspection is necessary, scheduling and conducting the inspection can add 2-4 weeks, depending on availability and logistics.
• Inspection Report: After the inspection, the preparation of the report and any required follow-up actions may extend the timeframe.

7. Final Review and Approval:

• Approval Issuance: Once all documentation and inspections (if any) are complete, CDSCO will review the final submission and issue a registration certificate. This final review and approval process typically takes 2-4 weeks.

Overall Timeframe:

• Average Duration: On average, the entire process from application submission to receiving CDSCO registration for a Class A medical device generally takes about 3-6 months.
• Potential Delays: Delays can occur due to incomplete submissions, additional information requests, or the need for facility inspections.

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