Regulated Product Submission

Working Group Chair(s)
Patrick Axtell
Food and Drug Administration (FDA)
United States of America
Daniel Yoon
Health Canada
Canada
Membership
Regulators
Status
Current

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

Fiona McCormack
Therapeutic Goods Administration (TGA)
Meryl Clarke
Therapeutic Goods Administration (TGA)
Simone McGinley
Therapeutic Goods Administration (TGA)
Tania Ahmed
Therapeutic Goods Administration (TGA)

Augusto Bencke Geyer
Brazilian Health Regulatory Agency (ANVISA)
Fabio Pereira Quintino
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)

Alana Hendry
Health Canada
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
Rainer Edelhäuser
Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices

Aya Komori
Pharmaceuticals and Medical Devices Agency (PMDA)
Dr Kentaro Kato
Pharmaceuticals and Medical Devices Agency (PMDA)
Dr Madoka Murakami
Ministry of Health, Labour and Welfare (MHLW)
Yuzuru Okazaki
Pharmaceuticals and Medical Devices Agency (PMDA)

Dawn Thibodeau
TUV - SUD
Sharmila Gardner
British Standards Institution (BSI)

Agnes Goh
Health Sciences Authority (HSA)
Koh Chee Gake
Health Sciences Authority (HSA)

Chung Keun Lee
Ministry of Food and Drug Safety (MFDS)
Yi Le Ahn (Rebecca)
Ministry of Food and Drug Safety (MFDS)
Yunju Lee
Ministry of Food and Drug Safety (MFDS)

Aiden Plant Patrick
Medicines and Healthcare products Regulatory Agency (MHRA)
Michael Messenger
Medicines and Healthcare products Regulatory Agency (MHRA)

Dr Kenneth Cavanaugh
Food and Drug Administration (FDA)
Patrick Axtell
Food and Drug Administration (FDA)

Helena Ardura-Garcia
World Health Organization (WHO)