Priority Review Scheme
What is the Priority Review Scheme?
The Priority Review Scheme (PRS) is an HSA programme that provides a faster turnaround time for medical devices submitted via the Full evaluation route, where the device meets specific criteria relating to unmet clinical need or significant health benefit.
The PRS does not reduce the documentation or evidence requirements — a full dossier is still required. It prioritises the application in HSA's review queue and aims for a shorter evaluation timeline.
Eligibility criteria
To qualify for Priority Review, a device must meet one or more of the following criteria:
- Addresses an unmet medical need — no alternative treatment or diagnostic option is currently available in Singapore;
- Provides a significant health benefit over existing treatments (e.g. substantially improved safety or efficacy);
- Addresses a serious or life-threatening condition where faster access to the device would benefit patients; or
- Is a device for a rare disease (orphan device equivalent).
How to apply
Priority Review status is requested at the time of submitting the full registration application via SHARE. The applicant must provide a justification for why the device meets the Priority Review criteria.
HSA will assess the eligibility claim as part of the application screening process.