Personal Import of Medical Devices in Singapore

1. Overview

Personal importation of medical devices for personal use is allowed in Singapore under certain conditions regulated by the Health Sciences Authority (HSA). This applies to individuals bringing or ordering devices from overseas for their own treatment or that of immediate family members. Commercial importation or resale is not permitted under personal import provisions. Source: https://www.hsa.gov.sg/medical-devices/personal-import

2. Allowed Quantity Limits

Individuals may import limited quantities without HSA authorisation:

• Up to 3 units or 3 months' supply (whichever is lower) of registered medical devices.
• Up to 1 unit or 1 month's supply for unregistered but HSA-approved devices under specific schemes.
• Higher quantities or unregistered high-risk devices generally require prior HSA authorisation.

These limits help prevent abuse while allowing reasonable personal access. Source: https://www.hsa.gov.sg/medical-devices/personal-import

3. Devices Requiring Prior Authorisation

The following typically require HSA approval before importation:

• Class C or D medical devices (higher risk).
• Unregistered devices.
• Devices containing controlled substances or narcotics.
• Devices for serious conditions where alternatives are unavailable locally.

Applicants must submit evidence of medical need (e.g., doctor's prescription or letter) and other supporting documents. Source: https://www.hsa.gov.sg/medical-devices/personal-import

4. Prohibited or Restricted Devices

Importation is prohibited or highly restricted for:

• Devices making unsubstantiated therapeutic claims.
• Counterfeit or tampered devices.
• Devices banned or withdrawn in Singapore or internationally.
• Certain aesthetic devices (e.g., high-powered lasers) without professional oversight.

Customs may seize non-compliant items at the border. Source: https://www.hsa.gov.sg/medical-devices/personal-import

5. Application Process for Authorisation

• Submit an online application via the HSA portal with required documents (prescription, device details, proof of overseas purchase/source).
• Processing time is typically 10–15 working days.
• If approved, an authorisation letter is issued for customs clearance.
• Keep records of authorisation and importation for compliance checks.

Source: https://www.hsa.gov.sg/medical-devices/personal-import

6. Important Responsibilities

• Importers must ensure the device is for personal use only (no resale or distribution).
• Devices must be accompanied by original labelling and instructions.
• Report any adverse events related to imported devices to HSA.
• Comply with customs declaration requirements when bringing devices into Singapore.

Source: https://www.hsa.gov.sg/medical-devices/personal-import

7. Important Notes

• Personal import does not replace proper medical consultation or local registered alternatives.
• Misuse of personal import provisions for commercial purposes may result in enforcement action.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/personal-import