Completing an application for consent to import, supply or export medical devices that do not meet UDI-related Essential Principles

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.