12 November 2014

Pre-market assessment of Australian-manufactured medical devices – Regulation Impact Statement – Department of Health

On 15 October 2014, the Australian Government announced changes to the regulation of therapeutic goods that will allow Australian manufacturers of medical devices to obtain market approval for most of their products using conformity assessment certification from European notified bodies.

Conformity assessment is the examination of evidence and procedures to ensure that both the medical device and the process used to make the device comply with the requirements of the therapeutic goods legislation. Under current arrangements, Australian manufacturers are required to have their products undergo conformity assessment by the Therapeutic Goods Administration (TGA) before their products can be marketed in Australia. If they wish to export their products, Australian manufacturers require an additional assessment by organisations certified by overseas regulators (‘notified bodies’). This is in contrast to overseas manufacturers, who only need to have their products assessed by the overseas notified bodies.

The proposed changes will allow Australian manufacturers to choose to either have conformity assessment conducted by the TGA or an alternative conformity assessment body, such as a European notified body. This will put Australian manufacturers of all but the highest-risk products on an equal footing with those from overseas, avoiding the need for duplicate conformity assessments for those manufacturers wishing to export their products to Europe. In many cases this could allow locally-made medical devices to get to market more quickly. The new rules will not apply to the very highest risk devices, including devices containing medicines or tissues of animal, biological or microbial origin, or Class 4 in vitro diagnostic devices: these devices will still need TGA conformity assessment.

The proposed rule changes have been assessed as likely to have a measurable but contained impact on the economy with minor impacts on competition. On 8 August 2013 a Regulation Impact Statement (RIS) canvassing the proposed changes was prepared by the Department of Health and was published. The RIS was subsequently finalised and certified by the Department consistent with Australian Government best practice regulation requirements, and the OBPR notes that the process followed by the department and the level of analysis contained in the RIS was consistent with best practice.

The RIS estimates the average annual regulatory cost saving at $6.12 million per annum. The OBPR has agreed to the regulatory cost saving.


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