The time cycle for applying for 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 regulatory review process. Here’s an overview of the typical time cycle and review process stages:

1. Time Cycle Overview

• Preparation Phase: 1 to 3 months

  • Technical Documentation Preparation: Compiling and preparing the required technical documents, including clinical data, risk management reports, and quality management system documentation.
  • Quality Management System Certification: If not already obtained, acquiring ISO 13485 certification and ensuring Good Manufacturing Practices (GMP) compliance.

• Application Submission: 1 to 2 weeks

  • Submission of Application: Filling out and submitting the application form through the CDSCO SUGAM portal, along with required documents and payment of fees.

• Initial Review: 1 to 2 months

  • Document Review: CDSCO reviews the submitted documents for completeness and accuracy.
  • Queries and Clarifications: CDSCO may request additional information or clarification. The time taken to address these requests can affect the overall timeline.

• Facility Inspection: 1 to 3 months (if applicable)

  • Inspection Scheduling: CDSCO may schedule an on-site inspection of the manufacturing facility. The timing depends on availability and scheduling.
  • Inspection Conduct: The duration of the inspection depends on the facility's compliance and any issues identified.

• Decision and Certification: 1 to 2 months

  • Review of Inspection Report: CDSCO reviews the inspection report (if an inspection was conducted) and makes a final decision.
  • Issuance of Certificate: Upon approval, CDSCO issues the registration certificate for the Class C medical device.

2. Review Process Stages

2.1. Application Submission

• Preparation: Ensure all documentation is complete and meets CDSCO requirements.
• Submission: Upload the application form and required documents on the SUGAM portal and make the payment.

2.2. Initial Review

• Document Check: CDSCO conducts a preliminary review of the submitted documents to verify completeness and accuracy.
• Queries: If CDSCO identifies any gaps or issues, they will request additional information or clarifications. Prompt responses to these queries are crucial.

2.3. Technical Evaluation

• Detailed Review: CDSCO’s technical experts conduct a detailed evaluation of the technical documentation, including clinical data, risk management reports, and compliance with standards.
• Consultation: In some cases, CDSCO may consult external experts or advisory committees for further evaluation.

2.4. Facility Inspection (if required)

• Inspection Planning: CDSCO schedules an inspection of the manufacturing facility to assess compliance with regulatory requirements and GMP standards.
• Conduct Inspection: The inspection team reviews manufacturing processes, quality control systems, and documentation.

2.5. Decision Making

• Review of Findings: CDSCO reviews the results of the technical evaluation and facility inspection (if applicable).
• Decision: A decision is made regarding the approval or rejection of the registration application.

2.6. Issuance of Registration

• Certification: If the application is approved, CDSCO issues a registration certificate for the Class C medical device.
• Notification: The applicant is notified of the registration approval and receives the certificate.

Summary of Time Cycle and Review Process

1. Preparation Phase: 1 to 3 months (preparing documentation and certification).
2. Application Submission: 1 to 2 weeks (submission and fee payment).
3. Initial Review: 1 to 2 months (document review and queries).
4. Facility Inspection: 1 to 3 months (scheduling and conducting inspection, if applicable).
5. Decision and Certification: 1 to 2 months (review of findings and issuance of certificate).