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
Kylie Downes
Therapeutic Goods Administration (TGA)
Simone McGinley
Therapeutic Goods Administration (TGA)
Augusto Bencke Geyer
Brazilian Health Regulatory Agency (ANVISA)
Mr Anderson de Almeida Pereira
Brazilian Health Regulatory Agency (ANVISA)
Alison Oldfield
Health Canada
Daniel Yoon
Health Canada
Hsing-Cheng (Johnny) Chou
Health Canada
Yue Min
Center for Medical Device Evaluation (CMDE), NMPA
Dalia Emad Eldin Mohamed
Egyptian Drug Authority (EDA)
Noha Osama El-Hariri
Egyptian Drug Authority (EDA)
Maria-Chiara Orlandi
European Commission
Rainer Edelhäuser
Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices
Hideharu Komiya
Pharmaceuticals and Medical Devices Agency (PMDA)
So Hifumi
Pharmaceuticals and Medical Devices Agency (PMDA)
Emmanuel Emori Armon
National Agency for Food and Drug Administration and Control (NAFDAC)
Pranav Patel
TUV - SUD
Purvi Patel
British Standards Institution (BSI)
Sharmila Gardner
Intertek
Agnes Goh
Health Sciences Authority (HSA)
Koh Chee Gake
Health Sciences Authority (HSA)
Young-Mee Kwon
Ministry of Food and Drug Safety (MFDS)
Yunju Lee
Ministry of Food and Drug Safety (MFDS)
Eve Hutchinson
MHRA - UK
Rebecca Riches-Duit
MHRA - UK
Dr Kenneth Cavanaugh
Food and Drug Administration (FDA)
Lili Duan
Food and Drug Administration (FDA)
Patrick Axtell
Food and Drug Administration (FDA)
Susie Braniff
World Health Organization (WHO)