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February 1, 2026
Approximately 5 minutes
Consignment Import of Registered Medical Devices in Singapore via SAR
Consignment Import of Registered Medical Devices in Singapore via SAR
1. Overview
The Consignment Registered Special Access Route (SAR) permits dealers who are not authorised by the registrant to import registered medical devices on a consignment basis, subject to approval from the Health Sciences Authority (HSA) under the Health Products Act. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/consignment-registered
2. Eligibility Criteria
Applicants must possess a valid importer's and wholesaler's licence, along with a Good Distribution Practice for Medical Devices (GDPMDS) certificate or ISO 13485 certification. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/consignment-registered
3. Application Process
Applications are submitted through the SHARE e-service at https://share.hsa.gov.sg/. Access requires CorpPass authentication. For technical issues, such as document upload failures, contact HSA_SHARE_Support@hsa.gov.sg with screenshots including the address bar and system time. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/consignment-registered
4. Required Documents
Mandatory documents include:
- SAR Device List (downloadable from SHARE)
- Instructions for Use, Product Insert, or Operations Manual from the product owner
- Primary medical device label
- Attestation from the product owner confirming the device is identical to the registered one in Singapore, including manufacturing site, packaging, and labelling (template available at https://www.hsa.gov.sg/docs/default-source/hprg-mdb/annex-4-r3-1-product-owner-authorisation-template-(18sep)_bcp.doc?sfvrsn=2813c4fa_2)
- SMDR listing number of the original registered device
- Evidence of registration in the exporting country (e.g., certificate of free sale)
- Certified true copy of ISO 13485 certificate for each manufacturing site
- Invoice copy from the exporting company indicating lot/serial numbers
- Undertaking by the importer accepting responsibility for quality, safety, and performance
- Declaration on Distribution Records (submitted within 30 days after last export/supply)
https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/consignment-registered
5. Validity and Renewal
The webpage does not specify validity periods or renewal processes for approvals under this SAR. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/consignment-registered
6. Fees
Fees and turnaround times are outlined in the medical device fees section at https://www.hsa.gov.sg/medical-devices/fees. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/consignment-registered
7. Important Notes
Importers not authorised by the registrant must obtain HSA approval. They assume full responsibility for the device's quality, safety, and performance. The Declaration on Distribution Records must be submitted post-import. Last updated: 17 Oct 2025. https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/consignment-registered
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