SME Profile

Shelley Tang

Ms Tang retired from Australia’s Therapeutic Goods Administration in July 2011.
During her time at the TGA, she spent 11 years in the Microbiology Section of TGA Laboratories specializing in the assessment of the sterile manufacture of medicines and devices, one year as Head of the Biomaterials and Engineering Section managing the program for the testing of medical devices and supervising the Medical Device Incident Reporting and Investigation Scheme, and ten years as Head of the Medical Device Assessment Section responsible for the program for conformity assessment of medical devices, including assessment done under Australia’s Mutual Recognition Agreement with Europe and the Memorandum of Understanding with Canada. She also led the development of the technical requirements for Australia’s new IVD regulatory scheme introduced on 1 July 2010. At the time of leaving the TGA, she held the position of Head of the Office of Devices Authorisation.
Ms Tang holds a Bachelor of Applied Science in Medical Technology majoring in microbiology and histopathology. Prior to her retirement, she was Chair of the Global Harmonisation Task Force Study Group 1 sub-group on IVDs, and a member of the International Standards Organisation Technical Committee 212 developing standards for IVDs.
She currently runs her own company, Stellar Consulting, providing consulting services both nationally and internationally on the regulation of medical devices, including IVDs, and working with the WHO to develop regulatory systems for IVDs in their target countries.