PurposeTo develop industry positions and decide on the strategic direction of MTAA on regulatory matters within the scope of the Therapeutic Goods Act, the Medical Devices Regulations and the Advertising Code, alignment with the new EU Medical Device Regulations of April 2017 and international regulatory harmonisation forums (IMDRF).
- Advise other MTAA strategic committees on regulatory matters and coordinate in areas of overlap (e.g. HTA review and regulatory review)
- Define the MTAA regulatory strategic plan and direction.
- Appoint the Chair and, if required, the Core Team of the Regulatory Forum.
- Consider and approve industry positions prepared and recommended by the Regulatory Forum.
- Manage the interaction with TGA via the RegTech forum.
MTAA Secretary: Val Theisz, Director of Regulatory Affairs
George Faithfull (Chair)
Elizabeth Van Den Akker
O & M Halyard Australia
Johnson & Johnson
Mölnlycke Health Care
Smith & Nephew