Medical devices are classified into one of four classes: Class A( lowest class), Class B, Class C and Class D (highest class ). Classification is risk based and depends on the intended use of the device and also upon indications for use.
Where a device has more than one specified purpose, the correct result will be based on the purpose with the highest classification. For example a catheter that is intended to be used short-term in peripheral arteries would be a Class B device. One that is intended to be used in the central circulatory system, would be a Class D device. If a manufacturer produced a catheter that was intended to be used in both the peripheral and central circulatory systems, it would be Class D because this is the highest classification for the device’s intended purpose.
Where more than one classification rule applies to the device, the correct classification is the highest classification. For example, a device used in surgery that depends on a source of energy would be covered by both ‘invasive’ device rules and ‘active’ device rules.
Where a device is used in combination with another medical device, the classification rules must be applied separately to each device. This includes any accessories to the medical device.
Where a medical device is driven or influenced by an item of software that is not embedded in the device, the software has the same classification as the medical device. This includes Apps on a mobile device like a smart phone or tablet.
If you would like a formal medical device classification from the NDA, consider submitting a formal request through the directorate of product assessment and registration registration@nda.or.ug
Standards
Uganda standards can be found by accessing the website ; https://webstore.unbs.go.ug/
