Regulatory Affairs Committee

 

Purpose

To 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).

 

Objectives

  1. Advise other MTAA strategic committees on regulatory matters and coordinate in areas of overlap (e.g. HTA review and regulatory review)
  2. Define the MTAA regulatory strategic plan and direction.
  3. Appoint the Chair and, if required, the Core Team of the Regulatory Forum.
  4. Consider and approve industry positions prepared and recommended by the Regulatory Forum.
  5. Manage the interaction with TGA via the RegTech forum.

MTAA Secretary: Val Theisz, Director of Regulatory Affairs

Member Name 

Company 

George Faithfull (Chair)

Stryker 

Jason Aldworth

3DMEDITech 

Mahesh Datar

Medtronic 

Cheryl Davey

Alcon 

Kea Dent

KD&A

Falko Thiele

Biotronik

Elizabeth Van Den Akker 

Abbott Vascular 

Renee Cotta 

Boston Scientific 

Ruth Shennan 

Device Technologies 

Laleetha Devi 

O & M Halyard Australia

Rebecca Gaudin 

Johnson & Johnson 

Sue Hunter 

Abbott Medical

Fleur Winslade 

Terumo 

Rachel Patrick

Mölnlycke Health Care 

Juliana William

Baxter Healthcare

Minta Chen

Smith & Nephew 

Maneesha Pillay

Edwards Lifesciences 

Ramon Ippolito Surgical Specialties