The TGA is launching an initiative known as the Medical Devices Vigilance Program (MDVP). This program will kick off with a 12-month pilot phase, strategically crafted to assist medical device sponsors in adhering to regulations and assuring the Australian public that sponsors are fulfilling their obligations.
More The Australian government has extended medical device reform deadlines due to the EU MDR transition, enabling manufacturers to obtain EU MDR certificates and sponsors to engage with the TGA under the new regulations until July 1, 2029. This adjustment aligns with the EU MDR transition's conclusion on December 31, 2028.
More The Therapeutic Goods Administration (TGA) will no longer accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices after May 26, 2023. Only approved IVD medical devices supported by ISO 13485 certificates will remain valid until the certificate expires.
More The Therapeutic Goods Administration (TGA) created a plan to help Australian medical device sponsors and stakeholders transition to the new EU Medical Device Regulation (MDR). The EU then extended the transition period, so the TGA reviewed its original plan. An updated strategy guideline has been published by the TGA regarding the transition and reclassification of certain medical devices.
More To mitigate the risk of nanomaterials, the amendment has been made by the Therapeutic Goods Administration (TGA) to the existing Essential Principle 7 to include the additional obligations. The amended Essential Principles checklist can be viewed and downloaded from TGA’s website.
More TGA offers an online publication service to provide market notifications to healthcare providers and/or end users as a result of the EU MDR Transition.
If ALL 6 of the eligibility criteria for streamlined market notifications are met, then the Online Notification Form is to be submitted.
For changes that do not meet ALL six criteria, the new recall notification(s) under TGA compliance will need to be followed.
Most medical devices included in the Australian Register of Therapeutic Goods (ARTG) are supported by an obtained EU MDD certification and may need to transition to the new EU MDR in order to continue to be supplied in Australia.
Yet, many manufacturers are currently dealing with challenges regarding the switch from the EU MDD to the EU MDR. This includes additional requirements for the quality management systems (QMS) of the manufacturer, requiring higher standards in the clinical report to support the patient safety when using the medical device, classification rules changes, and other detailed technical document requirements.
In Australia, the “Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)” and the “Reduction of Assessment Fees for Medical Devices Guideline”, both outline specific situations in which the assessment procedures and the assessment costs for medical devices may be reduced.
The guideline provides details on the criteria and the eligibility for TGA to determine whether the process can be reduced for application audit assessments and conformity assessments involving medical devices (including IVDs).
Australia's Therapeutic Goods Administration (TGA) provides a pathway to applicants to have the opportunity to be determined as a priority applicant for their medical devices. This means, that the application will be recognised as the 'front-of-queue' priority throughout the relevant assessment processes.
More Therapeutic Goods Administration (TGA) has announced to establish an Australian Unique Device Identification (UDI) in October 2020 and has published new regulations on the approval and use of medical devices. These new regulations created a thorough database for the traceability of medical devices based on the UDI and the adverse event system.
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