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This application is a service of the Singapore Government.

Health Sciences Authority

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)
Class A (sterile) 30
Risk Classification TAT for Registration (in working days)
Immediate Expedited Abridged Full Full (Priority Review Scheme)
Class B Immediate Registration upon Submission 60 100 160 120
Class C   120 160 220 165
Class D   180 220 310 235
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)
Class A (sterile) 20
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.