For Class A medical devices registered with the Central Drugs Standard Control Organization (CDSCO) in India, annual reviews are not specifically mandated. However, there are important aspects related to ongoing compliance and regulatory oversight:

Ongoing Obligations:

1. Post-Market Surveillance:

   • Monitoring: Manufacturers are required to monitor the performance of their medical devices once they are on the market. This includes reporting any adverse events or issues to CDSCO.
   • Compliance with Safety Standards: Continuous adherence to safety and performance standards is necessary throughout the device’s lifecycle.

2. Renewal of Registration:

   • Registration Validity: While there is no specific requirement for annual reviews, CDSCO registration is generally valid for a period of 5 years. Before the expiration of this period, manufacturers must apply for renewal to maintain the registration status.

3. Updating Information:

   • Changes and Amendments: Manufacturers must notify CDSCO of any significant changes to the device, such as modifications in design, labeling, or manufacturing processes. These changes might necessitate an update or amendment to the existing registration.

4. Compliance with Regulatory Updates:

   • Regulatory Changes: Adherence to any updates or changes in regulatory requirements set by CDSCO or other relevant authorities is crucial. Manufacturers should stay informed about any new regulations or guidelines that may impact their devices.

Key Points to Note:

• Renewal Application: Manufacturers should prepare and submit a renewal application well before the registration expires. This application will include updated documentation and compliance information.

• Post-Market Obligations: Regularly review and maintain records related to post-market surveillance, including safety reports and performance data.

• Regulatory Communication: Maintain open communication with CDSCO to address any regulatory inquiries, updates, or requests for additional information.