Track open and upcoming regulatory consultations relevant to the MedTech sector.
The TGA is seeking external review of recent updates to the Essential Principles Checklist, which are intended to clarify which UDI-related Essential Principles manufacturers must…
Update: Feedback deadline for this consultation has been extended to COB Wednesday 30 September. If you haven’t already, please send through your feedback as soon…
The Australian Commission on Safety and Quality in Health Care (ACSQHC) has released the initial draft of the NSQHS Standards (third edition) for public consultation,…
The Therapeutic Goods Administration (TGA) is seeking feedback on options and proposed changes to improve the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the…
The International Medical Device Regulators Forum (IMDRF) has opened a public consultation on its draft document N93: Technical Framework for Artificial Intelligence Life Cycle Management,…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published proposed changes to the pre-market regulatory requirements for medical devices and in vitro diagnostic…
The IMDRF Quality Management Systems Working Group is seeking your feedback, which will be considered prior to finalisation of the attached guidance document for publication. This…
[EXTENDED – Feedback now due COB Thursday, 25 June] The TGA is proposing regulatory amendments to allow Instructions for Use (IFUs) for medical devices to…
The TGA is seeking targeted feedback on a proposed update to their audit selection guidance for medical device applications. The draft text clarifies how UDI…
The Therapeutics Goods Administration (TGA) is seeking feedback on a draft guidance document outlining our approach to predetermined change control plans (PCCPs). This guidance has…
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