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February 2, 2026
Approximately 5 minutes
Singapore HSA Special Access Routes for Export of Unregistered Medical Devices
Singapore HSA Special Access Routes for Export of Unregistered Medical Devices
1. Overview of Export Special Access Routes
Unregistered medical devices may be exported from Singapore under special access provisions when they are not intended for local supply or use. These routes enable legitimate export activities such as demonstrations, exhibitions, performance testing, clinical trial supply, or personal use by travelers, without requiring full registration. The Singapore Authorized Representative or exporter must comply with specific notification or approval requirements depending on the purpose. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/export
2. Main Export Scenarios and Requirements
2.1 Export for Demonstration, Exhibition, or Performance Testing
- Devices for trade shows, exhibitions, or performance evaluation overseas
- Must be re-exported or returned to Singapore after the event/testing
- No local supply or use permitted
- Exporter submits notification via online portal at least 14 working days before export
- Required documents: device description, quantity, purpose statement, event details, proof of re-export intention
- HSA issues export confirmation upon review https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/export
2.2 Export for Clinical Trial Supply
- Devices supplied to overseas clinical trial sites
- Must comply with destination country's regulations
- Notification required if device is unregistered in Singapore
- Submit trial protocol summary, ethics approval (if available), quantity, and destination details
- Devices cannot be used or sold in Singapore https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/export
2.3 Export for Personal Use by Travelers
- Small quantities for personal medical use by departing travelers
- Devices must be carried by the individual or accompany them
- No commercial intent; limited to personal needs
- No formal notification required in most cases, but customs may request proof of personal use https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/export
3. Key Conditions and Restrictions
- Devices must remain under the special access purpose and not be diverted for local sale or use
- Exporter is responsible for ensuring compliance with destination country requirements
- HSA may request additional information or reject export if public health risks are identified
- Records of export and re-import (where applicable) must be maintained for inspection https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/export
4. Process and Timeline
- Submit notification or request via HSA online portal
- Processing time: Typically 10–14 working days for complete submissions
- Upon approval, receive export confirmation letter or reference number for customs clearance
- No registration number is assigned; devices remain unregistered for local purposes https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/export
5. Practical Considerations
These special access routes support Singapore's role as a medical technology hub by facilitating international demonstrations, trials, and exhibitions without unnecessary regulatory burden. Exporters should prepare clear documentation of purpose and ensure devices are not made available locally. Consultation with HSA is advisable for complex cases or high-risk devices. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/export
This framework balances export flexibility with regulatory control for unregistered medical devices. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/export
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