Australia – Conformity assessment certificates, changes to requirements for certain medical devices

Repeal of Regulation 4.1 of the Medical Devices Regulations

On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2020(link is external).

This means that from 28 July 2021, medical devices that contain medicines or materials of animal, microbial, recombinant or human origin; and Class 4 in vitro diagnostic (IVD) medical devices no longer require mandatory TGA conformity assessment certification.

Now sponsors can provide conformity assessment documents issued by notified bodies designated by a member state of the European Union to support an application for inclusion in the ARTG. These changes recognise the significantly enhanced standards, processes and clinical evaluation requirements contained in the European Union’s (EU) Regulations for Medical Devices and In Vitro Diagnostics(link is external). It is important to note that Australia has some different regulatory requirements to Europe (e.g.: biologicals) and therefore, the amendment to Regulation 5.3 provides for the TGA to audit applications to ensure the information provided meets the Australian regulatory requirements (see below for further information). This ensures that safety and performance is demonstrated prior to approving the device for supply in Australia…