Nov 29, 2021

The Australian Therapeutic Goods Administration (TGA) has rolled out several updates in recent weeks affecting regulations of medical devices and in vitro diagnostic (IVD) products. Changes affect areas such as clinical evidence guidelines, reclassification of certain devices and post-market monitoring requirements for Australian market registrants.

Key TGA regulatory updates are discussed below.

Fee reductions for noncompliance

First, Australian regulators have reduced application fees for medical devices and IVDs that are noncompliant to Essential Principle 13A, which pertains to patient information materials. Manufacturers and sponsors of qualifying devices may contact the TGA to determine eligibility for refunds.

Changes to TGA clinical evidence guidelines

Second, the TGA has issued new guidance revising general requirements for clinical evidence for medical devices and IVDs. The new guidance overhauls the structure of the TGA’s clinical evidence guidelines, and specifies requirements for both medical devices and IVDs. For IVD manufacturers and sponsors, the TGA recommends utilizing the new guidance in conjunction with an existing supplement covering clinical evidence guidelines published for IVD devices.

Medical device post-market monitoring and reporting changes

Third, the TGA has announced ongoing plans to enhance medical device post-market monitoring and reporting processes in Australia to improve both patient safety and communication among stakeholders. Planned changes include an extended period for sponsors to submit final reports regarding adverse events, from 90 days currently to 120 days following their initial adverse event reports.

Update on up-classification of some surgical mesh devices

In addition, the TGA has published revised guidance regarding the planned reclassification of non-urogynecological surgical mesh implant devices in Australia. In order to avoid cancellation of their existing entries in the Australian Register of Therapeutic Goods (ARTG), sponsors of affected devices will have to either obtain or have applied to the TGA for appropriate Class III device conformity assessment certificates before December 1, 2021. Or, manufacturers of affected devices should have applied for ARTG Class III device entries either by December 1, 2021 or within six months of obtaining appropriate conformity assessment certificates for their devices.

Reclassification of devices introduced into the human body

Last, the TGA has issued new guidance related to reclassification of medical devices that are substances introduced into the human body or applied to skin. Sponsors of affected devices that either already have ARTG entries or that have applied for ARTG entries prior to November 25, 2021 must notify the TGA by May 25, 2022 and then submit ARTG inclusion applications reflecting their new device classifications begore November 1, 2024.

Learn more about Australia TGA medical device regulatory requirements at Emergo by UL:

Author

  • Stewart Eisenhart

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