Australia – Guidance for Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices

This guidance applies to the Declaration of Conformity procedures for Class I non-sterile, non‑measuring medical devices, Class 1 in vitro diagnostic (IVD) devices and Class I Systems and Procedure Packs.

This document is designed to assist manufacturers in completing the relevant Declaration of Conformity and to assist sponsors confirming that documentation prepared by the manufacturer is complete.

Sponsors must obtain a Declaration of Conformity from the manufacturer to upload as part of their application for inclusion in the ARTG of a Class I non-sterile, non-measuring medical devices, Class 1 IVD devices and Class I Systems and Procedure Packs. This guidance is not legislative in nature and is subject to the requirements of therapeutic goods legislation…