Regulatory Affairs Committee

Objectives: 

  • To support the in strategic development and delivery of Association policies in matters pertinent to its expertise.
  • To discuss operational issues facing the Association’s members in their interactions with the Therapeutic Goods Administration (TGA) in meeting the regulatory requirements for supplying medical technology in Australia.
  • To develop and submit papers, proposals and feedback to the TGA on regulatory issues through the TGA/Industry Regulatory and Technical Consultative Forum.
  • To support the Board in the strategic development and delivery of Association policies in matters pertinent to its expertise as determined by the Board from time to time.
  • To develop regulatory focused strategic initiatives for the Association, including:
    • a) reviewing the effectiveness of the regulatory system for medical technology in Australia
    • b) contributing to the Association’s involvement with international regulatory organisations
    • c) liaising with Australian government departments and industry associations in Australia and overseas, and
    • d) providing advice on the professional development of regulatory staff in the medical technology sector.

MTAA Secretary: Val Theisz, Director Regulatory & Clinical Affairs, Code of Practice    

Member Name

Company

Mahesh Datar (Chair)

Medtronic

George Faithfull (Vice Chair)

GeorgeFaithfull Advisory P/L

Falko Thiele

Biotronik

Jason Aldworth

3DMEDITech

Grant Woolcott

Teleflex Medical

Naeema Mohamed

Zimmer Biomet

Leanne Hartge

3M Healthcare

Rachel Patrick

Mölnlycke Health Care

Grace Shen

Alcon Laboratories

Elizabeth Van Den Akker

Abbott Vascular

Renee Cotta

Boston Scientific

Ruth Shennan

Device Technologies

Rebecca Gaudin

Johnson & Johnson

Sue Hunter

Abbott Medical

Fleur Winslade

Terumo

Juliana William

Baxter Healthcare

Minta Chen

Smith & Nephew

Maneesha Pillay

Edwards Lifesciences

Sarah Timms

Fresenius Medical Care

Sarah Botros

Stryker

 

Meeting dates for 2020: 

  • Wednesday, 24 February
  • Wednesday, 24 March
  • Wednesday, 5 May
  • Wednesday, 26 May
  • Wednesday, 1 September
  • Wednesday, 22 September
  • Wednesday, 3 November
  • Wednesday, 24 November

The Committee supports, takes direction from and reports to the Public Affairs Committee.