Regulated Product Submission
The charter of this working group is to build on the common Table of Contents for medical device regulatory submissions and create a dynamic template that supports the electronic transmission of regulatory submissions.
Technical/Informational document
Participants
Leon Weekes
Therapeutic Goods Administration (TGA)
Shraddha Swarmi
Therapeutic Goods Administration (TGA)
Simone McGinley
Therapeutic Goods Administration (TGA)
Tania Ahmed
Therapeutic Goods Administration (TGA)
Augusto Bencke Geyer
Brazilian Health Regulatory Agency (ANVISA)
Mr Anderson de Almeida Pereira
Brazilian Health Regulatory Agency (ANVISA)
Priscilla Consigliero de Rezende Martins
Brazilian Health Regulatory Agency (ANVISA)
Alison Oldfield
Health Canada
Daniel Yoon
Health Canada
Hsing-Cheng (Johnny) Chou
Health Canada
Shiqing Zhang
National Medical Products Administration (NMPA)
Yue Min
Center for Medical Device Evaluation (CMDE), NMPA
Maria-Chiara Orlandi
European Commission
Mario Gabrielli-Cossellu
European Commission
Rainer Edelhäuser
Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices
Dr Madoka Murakami
Ministry of Health, Labour and Welfare (MHLW)
Hideharu Komiya
Pharmaceuticals and Medical Devices Agency (PMDA)
So Hifumi
Pharmaceuticals and Medical Devices Agency (PMDA)
Yuzuru Okazaki
Pharmaceuticals and Medical Devices Agency (PMDA)
Dawn Thibodeau
TUV - SUD
Elle Helgeman
Intertek
Martin Witte
TUV - SUD
Sharmila Gardner
British Standards Institution (BSI)
Agnes Goh
Health Sciences Authority (HSA)
Koh Chee Gake
Health Sciences Authority (HSA)
Yi Le Ahn (Rebecca)
Ministry of Food and Drug Safety (MFDS)
Young-Mee Kwon
Ministry of Food and Drug Safety (MFDS)
Dr Kenneth Cavanaugh
Food and Drug Administration (FDA)
Patrick Axtell
Food and Drug Administration (FDA)
Helena Ardura-Garcia
World Health Organization (WHO)