No, Class B medical device registration with the Health Sciences Authority (HSA) in Singapore does not require annual renewal. However, it is subject to renewal every 5 years.

Key Points About Renewal:

1. 5-Year Renewal Period: The registration for Class B medical devices in Singapore is valid for 5 years from the date of registration. After this period, you will need to renew the registration to continue marketing and distributing the device in Singapore.

2. Application for Renewal: You will need to submit a renewal application to HSA before the current registration expires. It's advisable to initiate the renewal process well in advance (typically 6 months before the expiration) to ensure there is no gap in the registration status.

3. Documentation for Renewal: The renewal process often involves submitting updated information, which may include:

   • Updated safety and performance data (e.g., adverse event reports, clinical performance).
   • Changes to product labeling or other product-related information.
   • Compliance with current regulatory requirements or any new standards.

   If there have been significant changes to the device or its manufacturing process, you may be asked to provide additional documentation or updates to your risk management file, clinical data, or quality management system (QMS).

4. Conditions for Renewal: HSA may refuse the renewal if the device is found not to meet the regulatory requirements or if there are outstanding compliance issues, such as failure to report adverse events or improper manufacturing practices.

Summary

• Renewal Period: Every 5 years.
• No Annual Renewal: Class B medical devices do not require annual renewal, but the registration must be renewed at the end of the 5-year period.
• Preparation: Plan ahead for renewal by ensuring that you have the necessary documentation and that your device continues to meet all regulatory requirements.