No, annual review is not required for D-class medical device registration in Singapore. However, there are certain post-market obligations and requirements that manufacturers must adhere to, which may include:

1. Renewal of Registration

• Validity Period: The registration of a D-class medical device is valid for 5 years from the date of approval.
• Renewal: Before the 5-year period expires, the manufacturer must apply for renewal of the registration if the device is still being marketed in Singapore. This typically involves submitting updated documentation, ensuring continued compliance with HSA’s regulatory requirements.

2. Post-Market Surveillance and Reporting

• Even though there is no annual review, manufacturers are required to monitor the performance and safety of the device throughout its lifecycle. This includes:
  • Reporting any adverse events or device-related issues to HSA.
  • Keeping track of the device’s performance and any safety concerns.

3. Updates to Regulatory Information

• If there are any changes to the device, such as modifications to its intended use, manufacturing process, or labeling, the manufacturer must inform HSA and update the registration accordingly.

4. Compliance with Changes in Regulations

• Manufacturers should stay informed about any changes to HSA's regulations or standards, which may require updates to the device’s registration or documentation.

In summary, while there is no annual review required for D-class devices, manufacturers must comply with ongoing post-market obligations and renew the registration every 5 years. They must also report adverse events, update regulatory information, and follow any changes in regulations.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn