Import, manufacture or supply of custom-made medical devices

Custom-made medical devices do not need registration if they meet the criteria. Dealers need to update us on their list of custom-made devices.

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 design and construction specifications as requested by the qualified practitioner
  • The device is intended for use on one individual only
  • The device is not adapted from a mass-produced medical device

For dealers

You must have a valid dealer's license to import, manufacturer and supply custom-made medical devices to the requesting qualified practitioner or PHMC:

  • 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 PHMCs

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.

Obligations

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.

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