Regulated Product Submission

Working Group Chair(s)
Patrick Axtell
Food and Drug Administration (US 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.

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
Ministry of Health, Labour and Welfare (MHLW)
Rebecca Riches-Duit
Ministry of Health, Labour and Welfare (MHLW)

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

Susie Braniff
World Health Organization (WHO)

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Switzerland, Swissmedic

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Costa Rica - Ministry of Health

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Dominican Republic - General Directorate of Medicines, Food and Health Products (DIGEMAPS)

Egypt - Egyptian Drug Authority  (EDA)

El Salvador - Sanitary Regulation Superintendency (SRS)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

India - Central Drugs Standard Control Organization (CDSCO)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Affiliates

 

Jordan - Jordan Food and Drug Administration (JFDA)

Kenya - Pharmacy and Poisons Board (PPB)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Zimbabwe - Medicines Control Authority (MCAZ)