Australia’s Therapeutic Goods Administration (TGA) proposed in July 2023 to develop a framework for audits for premarket device applications, but the Medical Technology Association of Australia (MTAA) registered several concerns about the proposal.
Medical Microinstruments Inc. (MMI) is expanding its Symani surgical system into the Asia Pacific – a region with “clear demand for the technology” – through two local partners, Device Technologies Australia Pty Ltd. and Seoul-based TRM Korea Corp.
Australia’s Therapeutic Goods Administration (TGA) posted a Sept. 6 hazard alert for the Scandinavian Total Ankle Replacement (STAR) device by DJO Global, a subsidiary of Wilmington, Del.-based Enovis Corp. TGA said the polyethylene insert used to eliminate friction between the device’s moving parts has demonstrated a higher-than-expected fracture rate, and that the device has been delisted from the Australian Register of Therapeutic Goods (ARTg).
The recent decision by the EU to delay the implementation dates for the Medical Device Regulation (MDR) initiative is having ripple effects across the globe as other regulatory jurisdictions amend their policies to keep pace. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and Australia’s Therapeutic Goods Administration (TGA) have both revised their strategies to align with the latest MDR delay, giving devices that will remain available in the EU a similar extension in the U.K. and Australia.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
Australia’s Therapeutic Goods Administration (TGA) is proposing that devices be subject to good clinical practices (GCP) inspections, and it is proposing two approaches to achieve that goal.
Australia’s Therapeutic Goods Administration (TGA) should better align its definitions and classifications for gene, cell and tissue frameworks with international regulators, stakeholders said.
Australia’s Therapeutic Goods Administration (TGA) should better align its definitions and classifications for gene, cell and tissue frameworks with international regulators, stakeholders said.
Regenerative medicine company Orthocell Ltd. reported final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with regenerative nerve repair device Remplir.