No, Class C medical device registration with Singapore HSA does not require an annual review. However, there are certain periodic obligations and requirements that manufacturers must adhere to in order to maintain the registration.

Key Points:

1. Registration Validity: The registration for Class C medical devices is typically valid for 5 years.

2. Post-Market Surveillance:

   • Although there is no annual review, manufacturers are required to implement post-market surveillance. This includes monitoring the safety and performance of the device once it is on the market and reporting any adverse events or device-related issues to HSA.
   • Adverse event reporting is mandatory. If there are any significant safety concerns or adverse events related to the device, manufacturers must inform HSA promptly.

3. Periodic Updates:

   • Renewal: After 5 years, manufacturers must submit a renewal application to keep the registration valid. This may involve providing updated documentation or confirming that the device continues to meet HSA's regulatory standards.
   • If there are any significant changes to the device (such as design changes, new indications for use, or updated clinical data), manufacturers must inform HSA and may need to submit an updated application for approval.

4. Continuous Compliance:

   • Manufacturers must continue to comply with relevant regulatory standards and maintain the necessary documentation (e.g., quality management systems, risk management reports, etc.).
   • If there are significant updates to international standards or HSA regulations, manufacturers may need to update their devices or documentation to ensure ongoing compliance.

In Summary:

While there is no annual review for Class C medical device registration with Singapore HSA, manufacturers must ensure ongoing post-market surveillance, report any issues or adverse events, and renew the registration every 5 years. Additionally, they must keep HSA informed of any significant changes to the device or its use.

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