Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 27, 2026
Approximately 5 minutes
Qualified Practitioner Request for Unregistered Medical Devices in Singapore
Qualified Practitioner Request for Unregistered Medical Devices in Singapore
1. Overview
The Qualified Practitioner Request Special Access Route (SAR) enables the import and supply of unregistered medical devices in Singapore at the request of a qualified practitioner (doctor or dentist) for use on their patient. HSA approval is required in emergencies or when all available therapies fail. This applies to special clinical needs like compassionate use, preventing stockouts, or for novel/established devices. HSA does not assess safety and performance. Capital equipment requires registration. Long-term supply recommends registration. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/qualified-practitioner-request
2. Eligibility
Applicants need a certified quality management system like GDPMDS. Dealers and practitioners must comply with other regulations, e.g., Radiation Protection Act. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/qualified-practitioner-request
3. Conditions for Use
Requests are valid if:
- Compassionate Use: No alternatives; alternatives failed/ineffective/unsuitable; patient's health compromised without device.
- Preventing Out-of-Stock: Minimizes disruption to similar registered devices.
- Novel or Established Device: No registered alternatives/specific features; registered devices ineffective/unsuitable; practitioner familiarity enhances safety; patient's health compromised without it.
4. Application Process
Submit via SHARE portal at https://share.hsa.gov.sg/. Requires CorpPass. For issues, email HSA_SHARE_Support@hsa.gov.sg with screenshots. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/qualified-practitioner-request
5. Required Documents
- SAR Device List (from SHARE)
- Request form (https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/request-form-for-unregistered-medical-device-for-use-on-patients-by-qp-and-licensed-hcf(2025-sep).pdf?sfvrsn=8abec15f_1)
- MOH Clinical Justification Review Form (for PHIs, Class D devices: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/moh-clinical-justification-review-form-for-unregistered-class-d-medical-device.docx?sfvrsn=c148149c_2)
- Instructions for Use/Product Insert/Operations Manual
- Primary label
- Practitioner's registration copy (MCR/DCR Number)
- QMS certificate copy (e.g., GDPMDS)
- Declaration on Distribution Records (within 30 days post-expiry)
6. Fees and Turnaround Time
Details at https://www.hsa.gov.sg/medical-devices/fees. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/qualified-practitioner-request
7. Notes and Updates
Device for single-patient use. Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/qualified-practitioner-request
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Singapore HSA Priority Review Scheme for Medical Devices
The Health Sciences Authority (HSA) of Singapore operates a Priority Review Scheme to accelerate evaluation of medical devices that address unmet clinical needs, represent breakthrough innovations, or provide significant public health benefits, offering reduced review timelines while upholding rigorous safety and efficacy standards.
Approximately 5 minutes
Singapore HSA Special Access Routes for Export of Unregistered Medical Devices
The Health Sciences Authority (HSA) of Singapore provides special access routes allowing export of unregistered medical devices under specific conditions, such as for demonstration, exhibition, testing, clinical trial supply, or personal use, with streamlined notification or approval processes to facilitate legitimate international trade while maintaining regulatory oversight.
Approximately 5 minutes
Singapore HSA Special Access Routes for Non-Clinical Purpose Medical Devices
The Health Sciences Authority (HSA) of Singapore permits the import, export, or supply of unregistered medical devices for non-clinical purposes such as demonstration, exhibition, performance testing, research, or training through a streamlined special access notification process, enabling controlled use without full registration while ensuring no patient exposure.
Approximately 5 minutes
Consignment Import of Registered Medical Devices in Singapore via SAR
The Consignment Registered Special Access Route allows unauthorised dealers to import registered medical devices in Singapore with HSA approval, requiring specific licences and documentation.