Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form
Recently on 27th June, 2023 Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form for lapses in Medical Device Conformity Assessment Certification".
Guidance for Completing a Notification Form for Lapses in Medical Device Conformity Assessment Certification:
This guidance document provides advice on how to submit a notification for lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s). The guidance outlines the necessary steps and information required when notifying the TGA about instances where a medical device no longer meets the conformity assessment requirements.
This guidance aims to assist manufacturers and sponsors in properly documenting and reporting such lapses to ensure transparency and regulatory compliance in the field of medical devices.
Guidance on Reclassification of Surgical Mesh Devices
Surgical mesh medical devices are a variety of surgical implants usually used in the repair of soft tissue, or mixed soft tissue/bony structural defects, to support organs and/or tissues or to strengthen the integrity of a body cavity. Surgical mesh is implanted in the body for repair or reinforcement and includes tapes and slings.
This guidance is for sponsors of surgical mesh medical devices, and to assist the TGA's assessors when dealing with device applications and entries affected by the re-classification requirements.
In addition, there was another guidance"Information for medical practitioners on up-classification of surgical mesh devices" that aims to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1 December 2021.
All spinal implantable medical devices are currently classified as Class IIb medical devices under the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
The purpose of this guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements.