GHTF Steering Committee Chair

Dr. Roland Rotter (Chair)
Director - Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Room 1605 - Statistics Canada Main Building #3
Postal Locator 0301HI, Tunneys Pasture
Ottawa Ontario K1A 0L2
CANADA
Tel: +1 613 957 4786
Fax: +1 613 957 7318
e-mail: GHTF_Chair@hc-sc.gc.ca

Biography

Dr. Roland Rotter is the Director of the Medical Devices Bureau at Health Canada. He received his M.Sc. and Ph.D. degrees in toxicology at the University of Manitoba and started working at Health Canada in March 1991 as a toxicologist. He was appointed the Director of the Medical Devices Bureau in 2002. For three years, Dr. Rotter served as a member of the editorial board of the Pharmacology and Toxicology Section of the Journal of Animal Science and was the Secretary/Treasurer/Newsletter Editor for the Canadian Society of Animal Science for over six years. He has also represented Health Canada as a temporary advisor to the World Health Organization and the Pan American Health Organization.

Under his leadership, the Medical Devices Bureau is responsible for regulating medical devices sold and used in Canada, including: the processing and review of moderate to high-risk device (Class II, III & IV) licence applications, clinical trial applications, Special Access applications, Quality Management System audits of manufacturers, health risk assessments, laboratory testing, risk communications, regulatory, policy and guidance document development, support to litigation activities, international relations and participation in the development of national and international standards pertaining to medical devices.

Since 2002, Dr. Rotter has been Health Canada’s representative on the Steering Committee of the Global Harmonization Task Force (GHTF). He assumed the position of Chair of the GHTF on July 1, 2008. He also sits as a member of several advisory committees to organizations pertaining to medical devices, including: the Ottawa Heart Institute Scientific Advisory Committee; the Canadian Agency for Drugs and Technologies in Health’s Devices and Systems Advisory Committee; and the Standards Council of Canada’s Canadian Advisory Committee for ISO/CASCO and Advisory Committee on Conformity Assessment.

Updated 8 July 2008

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