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February 1, 2026
Approximately 5 minutes
PHMC Request for Unregistered Medical Devices in Singapore
PHMC Request for Unregistered Medical Devices in Singapore
1. Overview
Licensed laboratories and medical facilities under the Healthcare Services Act (HCSA) require approval from the Health Sciences Authority (HSA) to import and supply unregistered medical devices for use on their patients. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/phmc-request
2. Eligibility Criteria
Applicants must have a certified quality management system, such as compliance with Good Distribution Practice for Medical Devices (GDPMDS). Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/phmc-request
3. Conditions for Use
Approval is granted in emergencies or when all available therapies fail. The Head of Department or equivalent must provide clinical justification for special needs, including:
- Compassionate use: No alternatives; alternatives failed/ineffective/unsuitable; patient's health compromised without the 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's familiarity enhances safety; patient's health compromised without it.
Dealers and practitioners must comply with other regulations, e.g., Radiation Protection Act. Capital equipment (e.g., X-ray, CT, MRI) does not qualify; registration is required. HSA does not assess safety/performance. For long-term supply, registration is recommended. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/phmc-request
4. Application Process
Submit applications via the SHARE portal at https://share.hsa.gov.sg/. Requires CorpPass. For technical issues, email HSA_SHARE_Support@hsa.gov.sg with screenshots including address bar and system time. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/phmc-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
- Copy of HCSA licence with legible Licence Number
- Copy of QMS certificate (e.g., GDPMDS if no valid Importer licence)
- Declaration on Distribution Records (within 30 days after authorisation expiry)
Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/phmc-request
6. Fees and Turnaround Time
Refer to 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/phmc-request
7. Important Notes
HSA does not assess device safety/performance. Register for long-term supply. No capital equipment under this SAR. Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/phmc-request
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