February 23rd – 27th 2026

Inform Items

1. The International Medical Device Regulators Forum (IMDRF) Adverse Event Terminology Working Group (AET WG) is responsible for developing and maintaining internationally harmonised terminology for reporting adverse events related to medical devices, including in vitro diagnostic devices.
   The AET WG has now published guidance documents to support regulators, industry, and healthcare professionals in the coding of adverse events for medical devices. The guidance aims to promote consistent and appropriate application of IMDRF adverse event terminology across reporting contexts.
   In addition, the group has developed a set of short quizzes to support learning and knowledge checking following review of the guidance materials.

Quizzes:

• IMDRF Adverse Event Report Coding Quiz – Fill in form
• IMDRF Scenario Quiz: Breast Implant Removal Quiz – Fill in form
• IMDRF Scenario Quiz: Patient monitoring unit telemetry issues – Fill in form
• IMDRF Scenario Quiz: Air bubbles in an Infusion Set – Fill in form

Action Items

1. There are three open consultations (available to access on RegConnect under the Resource Hub):

i) Conformity Assessment Procedures – you can populate the feedback excel sheet with your concerns. There a meeting with the TGA scheduled for Friday, March 6th between 10 – 11am to discuss Proposals 6 and 7 in detail, please let LAW know if you would like to attend and have not received the invite for the same.

ii) Determining When News Is Subject To Advertising Rules (New Guidance) – a targeted consultation shared earlier this week. This guidance is being developed to promote consistent interpretation of the advertising rules and to help address ongoing non-compliance related to the advertising of therapeutic goods, particularly in evolving digital environment. This is open for response on the platform until COB March 19th.

iii) Annual Charge Exemption (ACE) Scheme Compliance Program Updates – the proposed amendments relate to the conditions of participation in the TGA’s ACE Scheme. They aim to address issues identified through the ACE Scheme Compliance Program, including rising cases of sponsors not participating in compliance reviews and other instances of non-compliance which have previously gone undetected. This is open for response on the platform until COB March 16th.