Concurrent processing of Change Notification applications

As part of its ongoing initiative to improve regulatory efficiency, HSA’s Medical Devices Cluster (MDC) announced that up to two Change Notification (CN) applications may now be processed concurrently for the same medical device listing. Previously, only one CN application could be processed at a time for a medical device listing, which could delay the implementation of subsequent changes.
 

Submission considerations

Stakeholders should ensure that no more than two active CN applications are ongoing for the same medical device listing at the point of submission. Where a CN application includes a listing that already has two active CN applications, the application cannot be accepted for processing and will be rejected in its entirety.

As application fees are non-refundable, stakeholders are encouraged to verify the status of existing CN applications and plan their submissions accordingly.
 

Revision of GN-21 Guidance on Change Notification

In conjunction with the enhancement to the CN application process, HSA has revised the GN-21 Guidance on Change Notification. Stakeholders should refer to the latest version of GN-21 and provide a complete dossier in accordance with the applicable documentary requirements. The device form in the Singapore Health Product Access and Regulation E-System (SHARE) should also be updated accordingly at the point of submission to facilitate timely processing of applications.
 

Implications and Significance

The enhancement provides medical device stakeholders with greater flexibility when managing multiple changes to the same registered medical device listing. Allowing two CN applications to be processed concurrently may reduce delays where multiple regulatory changes need to be implemented within a similar timeframe. Stakeholders should review the revised GN-21 Guidance on Change Notification and ensure that submissions meet the latest documentary requirements. They should also carefully monitor active CN applications before making new submissions, as applications involving a listing that already has two active CN applications will be rejected in their entirety and application fees are non-refundable.

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Reference

HSA MEDICAL DEVICE GUIDANCE GN-21: Guidance on Change Notification for Registered Medical Devices