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This guide explains how to apply for consent to import or supply medical device(s) that do not meet Unique Device Identification (UDI) related Essential Principles (EPs).
It describes:
- UDI-related Essential Principles
- the reduced fee structure taking effect from 1 July 2026
- the consent application process.
Use this guide only when your application relates solely to UDI-related EPs. If your application includes both UDI and non-UDI EPs, you must:
- use the standard Consent to Supply (CtS) process
- pay the standard application fee.
Important note
The streamlined approval process and reduced fee will not be available to sponsors who submit a UDI CtS before 1 July 2026. For more information, see: Unique Device Identification Consent to Supply process.