Complying with the Unique Device Identification timeframes for medical devices

Purpose

We have prepared this guidance to help you as a sponsor or manufacturer understand your regulatory obligations under Australian therapeutic goods legislation. Specifically, this guidance document covers the timing of UDI implementation and when compliance with the UDI requirements will apply.

This guidance complements our guidance on the UDI regulations, which covers:

• medical devices and in vitro diagnostic (IVD) medical devices included in UDI regulations
• labelling requirements
• data submission requirements
• specific device requirements.

For this Guidance:

• we refers to the Therapeutic Goods Administration (TGA)
• you refers to sponsor or manufacturer of medical devices or IVD devices
• UDI record refers to a UDI-Device Identifier (UDI-DI) and related data published as a record to the Australian Unique Device Identification Database (AusUDID)
• UDI compliance start date refers to the date in which you must comply with UDI requirements for your device(s)
• existing devices refers to a device that is manufactured and labelled prior to the UDI compliance start date
• EU certificate refers to an overseas regulator conformity assessment document issued under either of the following (as in force from time to time):
  • Council Directive 93/42/EEC of the Council of the European Communities
  • Directive 98/79/EC of the European Parliament and the Council of the European Union.