Yes, annual review is required for Class C medical device registration with CDSCO in India. The regulatory framework mandates that manufacturers of Class C devices undergo periodic review to ensure ongoing compliance with safety, efficacy, and quality standards.

Key Aspects of the Annual Review

• Renewal of Registration: The registration certificate for Class C devices is valid for a specific period, often five years, but manufacturers must provide annual updates or renewals as part of ongoing compliance.
• Post-Market Surveillance: Manufacturers are required to monitor the performance of their devices in the market and report any adverse events or issues to CDSCO.
• Documentation Updates: Regular updates to documentation may be necessary to reflect changes in device design, manufacturing processes, or quality management systems.
• Compliance Checks: CDSCO may conduct periodic checks or inspections to ensure that the device continues to meet regulatory requirements and standards.

Process for Annual Review

1. Submit Updates: Provide any necessary updates to the CDSCO regarding device performance, quality management systems, or manufacturing processes.
2. Respond to Queries: Address any requests for additional information or clarifications from CDSCO.

3. Adverse Event Reporting: Report any adverse events or significant changes related to the device.

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