Singapore HSA Special Access Routes for Non-Clinical Purpose Medical Devices

1. Overview of Non-Clinical Special Access

Unregistered medical devices may be imported, exported, or supplied in Singapore solely for non-clinical purposes without full registration. These include activities such as trade demonstrations, exhibitions, performance testing, research and development, or professional training, provided there is no use on or supply to patients. The process involves a simple online notification to HSA, ensuring oversight while supporting industry activities like product showcases and technical evaluations. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/non-clinical-purpose

2. Eligible Non-Clinical Purposes

The special access route covers the following non-clinical uses:

• Demonstration or exhibition at trade shows, conferences, or industry events
• Performance testing or evaluation (e.g., bench testing, compatibility checks)
• Research and development activities (non-human use)
• Professional training or education of healthcare personnel
• Quality control or calibration purposes

All activities must strictly avoid any clinical application, patient contact, or commercial distribution for treatment/diagnosis. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/non-clinical-purpose

3. Notification Requirements

The Singapore Authorized Representative or importer/exporter must:

• Submit notification via HSA online portal before import/export/supply
• Provide device description, quantity, intended non-clinical purpose, duration, and location/details of use
• Declare that the device will not be used on patients or supplied for clinical purposes
• Indicate plans for disposal, return, or destruction after use
• Notification is typically processed within 5–10 working days https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/non-clinical-purpose

4. Key Conditions and Restrictions

• Devices must remain under the declared non-clinical purpose; any deviation requires new notification or registration
• No patient exposure or clinical data collection permitted under this route
• Records of receipt, use, and disposal must be maintained for HSA inspection
• High-risk devices may require additional safeguards or justification
• Unauthorized clinical use or supply results in regulatory action https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/non-clinical-purpose

5. Process and Timeline

• Submit complete notification online with supporting details
• HSA reviews for compliance and issues confirmation/reference number
• Use the confirmation for customs clearance (import/export)
• Post-use, confirm disposal/return via update or record-keeping
• No formal approval letter; confirmation suffices for most purposes https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/non-clinical-purpose

6. Practical Considerations

This route facilitates Singapore's position as a medical technology hub by supporting exhibitions, training, and R&D without full registration burden. Organizations should clearly document non-clinical intent and limit quantities to demonstrated needs. For repeated or large-scale activities, consider consulting HSA in advance. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/non-clinical-purpose

The framework ensures controlled access for legitimate non-clinical activities while protecting public health. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/non-clinical-purpose