Priority Review Scheme

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 35% shorter compared to the TAT for a standard full route.

Priority review routes

There are two routes for the scheme.

Route 1

The medical device meets both criteria below:

1. It belongs to one of the following focused healthcare areas:
   

   • Oncology

   • Diabetes

   • Ophthalmic diseases

   • Cardiovascular diseases

   • Infectious diseases

   • Skin diseases

2. 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

Route 2

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.

Application process

Opt in to scheme

Select the Priority Review Scheme while submitting your product registration application in SHARE.

Document submission

The documents you require for the full registration route are based on your device's risk classification:

• Class B

• Class C

• Class D

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).

For more information, e-mail hsa_md_tech@hsa.gov.sg.guide