The time required to apply for CDSCO registration of Class B medical devices and the stages of the review process are as follows:

1. Application Preparation

Time Required: Varies depending on the complexity of the device and the completeness of the documentation. Typically, this stage can take from a few weeks to several months.

Key Activities:

• Compile technical documentation.
• Ensure compliance with ISO 13485 and other relevant standards.
• Prepare labeling and packaging materials.
• Gather clinical and performance data.

2. Submission of Application

Time Required: Submission itself is generally a quick process once the application is complete.

Key Activities:

• Submit the completed application form along with all required documents and fees to CDSCO.

3. Initial Review

Time Required: Approximately 1-2 weeks.

Key Activities:

• CDSCO checks the completeness of the application and documents.
• Verification of fee payment.

4. Detailed Review

Time Required: Typically 1-3 months.

Key Activities:

• CDSCO conducts a thorough review of the technical, clinical, and performance data.
• Assessment of compliance with regulatory requirements and standards.

5. Request for Additional Information

Time Required: Variable, depending on how quickly additional information is provided. This can add several weeks to the overall timeline.

Key Activities:

• Respond to any requests for additional information or clarifications from CDSCO.

6. Inspection (if required)

Time Required: 1-2 months (if applicable).

Key Activities:

• CDSCO may conduct an inspection of the manufacturing facility to verify compliance with GMP and other standards.

7. Final Review and Decision

Time Required: A few weeks after completing the detailed review and any necessary inspections.

Key Activities:

• CDSCO makes a decision on the registration application based on the review and inspection outcomes.
• Issuance of the registration certificate if approved.

8. Issuance of Registration Certificate

Time Required: A few weeks after approval.

Key Activities:

• CDSCO issues the registration certificate and communicates the approval.

Overall Timeline

Estimated Total Time: Typically, the entire process from submission to receiving the registration certificate can take approximately 4 to 6 months. This timeline can vary based on factors such as the completeness of the application, the complexity of the device, and the need for additional information or inspections.

Summary of Stages

1. Application Preparation: Several weeks to months.
2. Submission: Quick once documents are prepared.
3. Initial Review: 1-2 weeks.
4. Detailed Review: 1-3 months.
5. Additional Information Requests: Variable.
6. Inspection (if required): 1-2 months.
7. Final Review and Decision: Few weeks.
8. Issuance of Certificate: Few weeks.

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