The QMN Weekly Bulletin

Australia Outlines Latest Proposals for Enhancing Device Scrutiny

Feb. 8, 2013

Australia’s Therapeutic Goods Administration (TGA) has released a series of proposals aimed at strengthening premarket evaluation of medical devices, including one that would allow devicemakers to use conformity assessment bodies other than the TGA.

The plan to end mandatory use of the TGA for conformity assessments, contained in Proposal C of the January consultation paper, was welcomed by industry. “At this stage the proposal only applies to lower-risk devices and is conditional upon acceptance of Proposal A,” said Anne Trimmer, CEO of the Medical Technology Association of Australia.

Proposal A would increase the range of devices requiring mandatory audits, which would be required before a product could be listed on the Australian Register of Therapeutic Goods (ARTG). This is intended to capture all Class IIb and Class III devices — including spinal implants, ankle and finger joints, gastric bands and maxillofacial implants.

“In effect, all surgically invasive medical devices intended for long-term use and implantable medical devices will require mandatory audits, Trimmer told IMDRM, adding the proposal has both resource and cost implications for sponsors.

Proposal B would increase transparency around TGA decisionmaking by publishing information considered during product reviews. The focus would be on information related to the degree of assessment a device underwent.

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