No, CDSCO registration for Class D medical devices does not require annual renewal. The registration for Class D medical devices is typically valid for 5 years. However, it is crucial to maintain compliance with regulatory requirements throughout the validity period.

Key Points Regarding Renewal and Compliance:

1. Registration Validity:

   • Duration: The registration certificate is valid for 5 years from the date of issuance.

2. Renewal Process:

   • Timing: Begin the renewal process well before the certificate expires—typically 6 months before the expiration date.
   • Requirements: Submit a renewal application with updated documentation, including any changes or updates to the device, manufacturing processes, or quality management systems.

3. Ongoing Compliance:

   • Post-Market Surveillance: Continue monitoring the device’s performance and report any adverse events or issues to CDSCO.
   • Regulatory Updates: Stay informed about any changes in regulations or guidelines that may affect your device and ensure continued compliance.

4. Inspection and Audits:

   • Facility Inspections: CDSCO may conduct inspections or audits during the registration period to ensure ongoing adherence to regulatory standards.

5. Documentation:

   • Updates: Maintain and update necessary documentation to reflect any changes in device information, manufacturing processes, or quality management systems.