The medical devices undergo conformity assessment before they are included in the ARTG list to ensure that the devices comply with the essential principles required by the Therapeutic Goods Administration (TGA), Australia. Essential principles basically outline the safety and performance characteristics that any device should meet, so that it can be sold in Australia. Similar to the process in the EU, conformity assessment in Australia is based on the risk class of the device. Therefore, the conformity assessment route to be followed by any device depends on its classification.

There are various Regulatory standards which apply to various types of devices. Complying with either one or more of the standards is required as an essential requirement. Identification of relevant standards applicable to the device and subsequent testing of the device to demonstrate its compliance to the standard becomes a pre-requisite.

Conformity assessment involves a systematic examination of the technical documents concerned with the device. The risk management, clinical evaluation, manufacturing process involved, and the vigilance activities handled by the manufacturer are the critical areas for assessment. Devices that are required to have a TGA Conformity Assessment certificate are listed in Regulation 4.1 of the Therapeutic Goods (Medical Devices) Regulations 2002. While a conformity assessment certificate issued by the TGA is pre-requisite for marketing majority of medical devices in Australia, the TGA also accepts conformity assessment certificate issued by the Notified Bodies in Europe. In addition, the TGA also accepts conformity assessment from countries that are part of the MDSAP (Medical Device Single Audit Program).

The conformity assessment requirements vary with the risk category of the device. Table No.1 details the classification-based conformity assessment process in Australia.

Conformity Assessment Process - Australia

Table No.1. Conformity Assessment Requirements of the Devices

The usual approval process of medical devices by the TGA looks like:

As detailed above, once the Conformity Assessment Certificate is received from the TGA, a Declaration of Conformity (DoC) needs to be prepared by the manufacturer declaring that the medical device complies with the applicable essential principles, classification rules and the conformity assessment route. However, unlike the Conformity Assessment Certificate, a European DoC is not accepted by the TGA.

The Australian market offers a promising landscape for medical device manufacturers, if the Regulatory requirements of the Therapeutic Goods Administration (TGA) are met., The conformity requirements and assessment process vary with risk class of device and IVD. Though the medical device regulations are well defined and transparent, navigating through them is complex and the manufacturers may seek support from the Regulatory partners for successful listing of the device.

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