The time cycle for applying for CDSCO registration of Class D medical devices involves several phases, and the review steps can vary based on the complexity of the device and the completeness of the application. Here’s an overview:

Time Cycle:

1. Preparation Phase:

   • Duration: Several weeks to months.
   • Activities: Gathering and preparing all necessary documentation, including technical files, clinical data, and quality management system details. This phase depends on the readiness of your documentation and the complexity of the device.

2. Application Submission:

   • Duration: 1 to 2 weeks.
   • Activities: Registering on the SUGAM portal, filling out the application form, and submitting all required documents and fees.

3. Initial Review:

   • Duration: 1 to 3 months.
   • Activities: CDSCO performs an initial review to ensure the application is complete and all required documents are submitted.

4. Detailed Review:

   • Duration: 3 to 6 months.
   • Activities: A detailed review of the technical documentation, clinical data, and manufacturing information. CDSCO may request additional information or clarifications during this stage.

5. Inspection (if applicable):

   • Duration: 1 to 2 months (if required).
   • Activities: CDSCO may conduct an inspection of the manufacturing facility or request additional evidence to verify compliance.

6. Approval and Issuance:

   • Duration: 1 to 2 months.
   • Activities: Issuance of the registration certificate upon successful review and verification.

Review Steps:

1. Document Verification:

   • Initial Assessment: CDSCO verifies that all required documents are complete and correctly submitted. Incomplete applications may be returned for correction.

2. Technical Evaluation:

   • Review of Technical Documentation: Detailed evaluation of the device’s design, performance, and safety data. This includes reviewing the Device Master File, clinical data, and manufacturing details.

3. Risk Assessment:

   • Risk Management Review: Assessment of the risk management process and documentation to ensure all risks are identified and mitigated.

4. Quality System Review:

   • QMS Compliance: Evaluation of the quality management system to ensure compliance with ISO 13485 or equivalent standards.

5. Clinical Evaluation:

   • Review of Clinical Data: Assessment of clinical trial data and reports to verify that the device meets safety and effectiveness criteria.

6. Inspection (if required):

   • Facility Inspection: On-site inspection of the manufacturing facility may be conducted to verify adherence to regulatory and quality standards.

7. Final Review and Decision:

   • Approval: After completing the review and any necessary inspections, CDSCO makes a decision on the registration. If approved, a registration certificate is issued.

Total Duration: The entire process typically takes about 6 to 12 months, depending on the complexity of the device and the efficiency of the submission.

Key Considerations:

• Prepare Thoroughly: Ensure that all documents are complete and accurate to avoid delays.
• Respond Promptly: Address any additional information requests or clarifications from CDSCO quickly to keep the process moving.