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January 29, 2026
Approximately 5 minutes
Import of Unregistered Pre-Owned Medical Devices Returned from Maintenance or Repair in Singapore
Import of Unregistered Pre-Owned Medical Devices Returned from Maintenance or Repair in Singapore
1. Overview
Licensed dealers may import unregistered pre-owned medical devices that were previously exported from Singapore for maintenance or repair, subject to prior approval from the Health Sciences Authority (HSA) under the Health Products Act. This route is limited to devices originally supplied by the dealer or registrant in Singapore. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/import-of-unregistered-pre-owned-devices-returned-from-maintenance-repair
2. Eligibility Criteria
The device must have been:
- Previously supplied by the applicant dealer or the registrant in Singapore.
- Exported for maintenance or repair only.
- Returned to Singapore after repair.
3. Application Process
Applications are submitted via the SHARE e-service platform at https://share.hsa.gov.sg/. Access requires CorpPass authentication. For technical issues (e.g., document upload failures), contact HSA_SHARE_Support@hsa.gov.sg with error screenshots including the address bar and system time. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/import-of-unregistered-pre-owned-devices-returned-from-maintenance-repair
4. Required Documents
Mandatory documents include:
- SAR Device List (downloadable from SHARE)
- Proof of prior export for maintenance/repair (e.g., export permit, shipping documents, customs clearance)
- Service/repair report from the overseas service provider detailing work performed
- Declaration from the overseas service provider confirming the device was only repaired/maintained (no modifications affecting safety/efficacy)
- Instructions for Use/Product Insert/Operations Manual (if changed)
- Primary label (if changed)
- Copy of valid importer's licence
- Copy of GDPMDS or ISO 13485 certificate
- Undertaking by the importer accepting responsibility for quality, safety, and performance
- Declaration on Distribution Records (submitted within 30 days after last import)
5. Important Conditions
- The device must remain identical in safety and performance to its original state before export.
- No modifications that could affect safety, quality, or performance are permitted.
- Changes to labelling or instructions require justification and documentation.
- Importer bears full responsibility for the device's quality, safety, and performance.
6. Fees and Turnaround Time
Fees and processing timelines are detailed in the medical device fees section at https://www.hsa.gov.sg/medical-devices/fees. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/import-of-unregistered-pre-owned-devices-returned-from-maintenance-repair
7. Notes and Updates
This route does not apply to new devices or those modified beyond repair. Last updated: 17 October 2025. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/import-of-unregistered-pre-owned-devices-returned-from-maintenance-repair
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