Conditions for dealing in custom-made medical devices
You are allowed to supply custom-made medical devices without registering them if your device meets all of the following requirements:
- The device is made at the request of a qualified practitioner
- The device is made according to the specification as requested by the qualified practitioner, regarding the design characteristics or construction* of the medical device
- The device is intended for use on one individual only
- The device is not adapted from a mass-produced medical device
*Design characteristics or construction is defined as:
Unique design specifications necessary to produce custom-made devices and which are based on an individual's specific anatomo-physiological features and/or pathological condition
You must have a valid dealer's license to import, manufacturer and supply custom-made medical devices to the requesting qualified practitioner or PHMCA/HCSA licensed healthcare facility:
- If you are importing and supplying a custom-made medical device, you will need an importer’s licence and a wholesaler’s licence respectively.
- A manufacturer will need a manufacturer's licence.
- You are not allowed to supply unregistered custom-made medical devices to consumers (i.e. retail supply) directly.
For PHMCA/HCSA licensed healthcare facilities
You can only custom-make medical devices in your licensed facilities without a Manufacturer's licence if the devices are intended for your own patients.
All importers and manufacturers of custom-made medical devices must e-mail us a list of custom-made medical devices
Additionally, dealers must keep records of the requesting qualified practitioner's prescription or equivalent as evidence that the device was custom-made based on the qualified practitioner's request and specifications for his patient. These records may
be requested from us for verification purposes.