The scheme applies only for Class B, C and D devices that are submitted under the full evaluation route, and excludes Class D devices with a registrable drug in a secondary role.
The turnaround time (TAT) for Priority Review Scheme is 25% shorter compared to the TAT for a standard full route.
Priority review routes
There are two routes for the scheme.
The medical device meets both criteria below:
- It belongs to one of five focused healthcare areas:
- Ophthalmic diseases
- Cardiovascular diseases
- Infectious diseases
- It is designed and validated for an unmet clinical need. This means either:
- It can be used to diagnose and treat a condition which has no other existing treatment
- It is a breakthrough technology with an edge over existing technology
The medical device does not meet the above two criteria.
Fees and turnaround time
Refer to medical device fees and turnaround time for more information.
Opt in to scheme
Select the Priority Review Scheme while submitting your product registration application in MEDICS.
The documents you require for the full registration route are based on your device's risk classification:
Request for information
HSA reviews if devices fulfil all qualification criteria for the selected Priority Review Scheme route and may request for further information or clarification via Input Request (IR).
Companies will be given 2 weeks to respond to HSA's IR. Failure to respond or address deficiencies may result in the application being switched to the full evaluation route without Priority Review Scheme.
For more information, e-mail firstname.lastname@example.org.