Singapore HSA Priority Review Scheme for Medical Devices

1. Purpose and Objectives

The Priority Review Scheme (PRS) aims to facilitate earlier patient access to innovative medical devices that meet important unmet clinical needs or provide substantial public health benefits. It applies to selected higher-risk devices (Class C and D) and certain lower-risk devices with breakthrough features, shortening HSA evaluation timelines compared to standard review while maintaining high regulatory standards for safety, quality, and performance. https://www.hsa.gov.sg/medical-devices/registration/priority-review-scheme

2. Eligibility Criteria

Devices may qualify for priority review if they satisfy one or more of the following:

• Address serious life-threatening or debilitating conditions with no satisfactory alternative treatment available in Singapore
• Represent a breakthrough technology offering significant clinical advantage over existing options
• Provide major improvement in diagnosis, treatment, or prevention of disease with substantial public health impact
• Are designated as breakthrough devices by stringent reference authorities (e.g., US FDA Breakthrough Devices Program) or equivalent programs https://www.hsa.gov.sg/medical-devices/registration/priority-review-scheme

3. Application Process

• The Singapore Authorized Representative submits a priority review request together with the registration application (or as a separate pre-submission request)
• Supporting evidence must demonstrate how the device meets PRS criteria (e.g., clinical data summaries, reference authority designation letters, unmet need justification)
• HSA assesses eligibility within a short timeframe and notifies the applicant of acceptance or rejection https://www.hsa.gov.sg/medical-devices/registration/priority-review-scheme

4. Review Timeline and Benefits

Upon acceptance into PRS:

• Target review timeline for Class D devices: Approximately 120 working days (versus ~210–270 for standard full review)
• Target for Class C devices: Approximately 90 working days (versus ~120–180 for standard)
• Focused evaluation on key safety, efficacy, and performance aspects, leveraging reference agency assessments where applicable
• No reduction in evidence requirements; full dossier still needed https://www.hsa.gov.sg/medical-devices/registration/priority-review-scheme

5. Scope and Limitations

• Applies primarily to higher-risk Class C and D devices; lower-risk devices may qualify in exceptional cases
• Does not guarantee approval; devices must still meet all regulatory standards
• Not applicable to abridged, expedited, or immediate registration routes
• Priority status may be revoked if new information materially changes the benefit-risk profile https://www.hsa.gov.sg/medical-devices/registration/priority-review-scheme

6. Post-Approval Obligations

Approved priority-reviewed devices remain subject to standard post-market requirements, including:

• Continuous post-market surveillance and vigilance reporting
• Change notifications for modifications affecting safety or performance
• Periodic registration renewal
• Compliance with Singapore-specific labeling, advertising, and distribution rules https://www.hsa.gov.sg/medical-devices/registration/priority-review-scheme

7. Practical Considerations

The PRS supports timely introduction of transformative medical technologies in Singapore by prioritizing devices with high clinical impact. Applicants should prepare strong justification and evidence of unmet need or breakthrough status. Early dialogue with HSA via pre-submission consultation is recommended to confirm eligibility and streamline the process. https://www.hsa.gov.sg/medical-devices/registration/priority-review-scheme

This scheme enhances patient access to innovative devices while preserving Singapore's high regulatory standards. https://www.hsa.gov.sg/medical-devices/registration/priority-review-scheme