Target Processing Timelines
Application for Medical Devices
HSA shall endeavour to meet the target processing timelines for all submitted applications. Applicants should ensure that the dossiers are complete before submission. Incomplete submissions and untimely responses to queries will result in unnecessary delays to the registration process and thus, will have a negative impact on the target processing timelines.
The target turn-around-time (TAT) for applications commences from the date of receipt of the application and does not include ‘stop-clock time' due to input requests for clarifications and additional information.
1. TAT for Product Registration applications:
|Risk Classification||TAT for Registration (in working days)|
|Immediate||Expedited||Abridged||Full||Full (Priority Review Scheme)|
|Class B||Immediate Registration upon Submission||100||160||120|
Immediate Registration upon submission
(for Class C standalone medical mobile application only)
|Class D, devices incorporating registrable medicinal / therapeutic products||220||310|
2. TAT for Change Notification (CN) applications:
|Risk Classification||TAT for Change Notification (in working days)
|Review Changes||Administrative Changes||Technical Changes|
|Class B||45||30||Not Applicable|
|Class C||Not Applicable||30||75|
|Class D *||Not Applicable||30||90|
For TATs with regards to changes to Class D medical devices that incorporate a registrable medicinal/therapeutic product in an ancillary role, please contact HSA.