Custom-Made Medical Devices
What is a custom-made medical device?
A custom-made medical device is a device that is manufactured specifically for a named individual patient, based on a written prescription from a qualified practitioner who takes responsibility for the design specifications. The device is not mass-produced and is not a device that has been adapted at the point of use.
Regulatory treatment
Custom-made medical devices are subject to a specific regulatory pathway under Singapore's framework. They are not required to go through the standard product registration process, but the manufacturer must:
- Comply with applicable quality and safety requirements;
- Maintain documentation on the device's design, manufacture, and the practitioner's prescription;
- Ensure that custom-made devices are only manufactured and supplied according to the specific prescription.
HSA's custom-made device guidance
Full details of the requirements for custom-made medical devices, including manufacturer obligations and documentation requirements, are on the HSA website:
hsa.gov.sg/medical-devices/custom-made-devices