Singapore Health Science Authority Publishes New Guideline for Approval of Next-Generation Medical Devices

The Health Science Authority (HSA) of Singapore has released a new guideline to streamline the approval process for next-generation medical devices, which allows manufacturers to leverage data from previously registered devices.

Medical devices often undergo enhancements based on real-world feedback and share common characteristics and validation data with their predecessors. However, next-generation devices are typically rebranded to highlight improvements and cannot use the Change Notification pathway intended to modify registered products in Singapore.

For general medical devices, the new guideline is applicable to Class B, C, and D devices (excluding MD-drug combinations) submitted under the FULL route. These devices must share the same product type and have identical validation for biocompatibility, sterilization, and shelf-life with the registered device.

For in-vitro diagnostic medical devices, the reagents must have identical formulations, storage conditions, intended use, indications for use, and sample type as the registered IVD device.

Additionally, the registered device must have the same product owner and registrant as the next-generation device. It must be listed on the Singapore Medical Device Register (SMDR) at the time of submission. Any changes to the registered device must be documented via a REVIEW or TECHNICAL Change Notification.

The application dossier, which includes the “NEXTGEN MD” form, must be submitted via MEDICS. Failure to include sufficient information in the application dossier will result in the application being evaluated via the FULL route.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)