Custom-Made Medical Devices Regulatory Pathway in Singapore

1. Overview

Custom-made medical devices are individually manufactured according to a written prescription from a qualified practitioner for the sole use of a particular patient. These devices are exempt from full product registration under the Health Products Act but must comply with specific regulatory requirements, including notification to HSA. Source: https://www.hsa.gov.sg/medical-devices/custom-made-devices

2. Definition and Scope

A custom-made device is defined as any device specifically made in accordance with a written prescription by a qualified practitioner which gives, under his responsibility, specific design characteristics, and is intended for the sole use of a particular patient. Source: https://www.hsa.gov.sg/medical-devices/custom-made-devices

This category excludes:

• Devices produced in mass with standard specifications even if adapted to meet the needs of a particular patient.
• Devices intended for clinical investigation or performance evaluation.

Source: https://www.hsa.gov.sg/medical-devices/custom-made-devices

3. Exemption from Registration

Custom-made devices are exempt from product registration requirements. However, manufacturers, importers, or suppliers must notify HSA of their intention to supply such devices. Source: https://www.hsa.gov.sg/medical-devices/custom-made-devices

4. Notification Requirements

• Submit a notification to HSA before supplying the custom-made device.
• Notification is required for each unique custom-made device or when there is a change in the manufacturer, importer, or supplier.
• Use the appropriate form or process specified by HSA.

Source: https://www.hsa.gov.sg/medical-devices/custom-made-devices

5. Labelling and Documentation Obligations

Custom-made devices must be labelled with:

• The name or trade name of the device.
• The name and address of the manufacturer.
• The statement "custom-made device".
• The name of the patient for whom the device is intended (if practicable).
• Any necessary instructions for use and warnings.

The prescription and design specifications must be documented and retained by the manufacturer. Source: https://www.hsa.gov.sg/medical-devices/custom-made-devices

6. Record-Keeping Requirements

Records must be maintained for at least 5 years (or longer if specified) and include:

• The prescription from the qualified practitioner.
• Design specifications and manufacturing details.
• Identity of the patient.
• Any adverse events or complaints related to the device.

These records must be available for inspection by HSA upon request. Source: https://www.hsa.gov.sg/medical-devices/custom-made-devices

7. Important Notes and Compliance

• The qualified practitioner assumes clinical responsibility for the prescription and use of the device.
• Manufacturers must ensure the device is manufactured under appropriate quality controls.
• Non-compliance may result in regulatory action.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/custom-made-devices