Foundational Documents

Working Group Chair(s)
Wil Vargas
Food and Drug Administration (US FDA)
United States of America
Tan Yuhua
Health Sciences Authority (HSA)
Singapore
Membership
Regulators and Industry Stakeholders
Status
Current

Regulatory harmonisation is foundational to enabling medical device regulators worldwide to establish frameworks that are aligned and consistent. As a global leader in this domain, IMDRF plays a central role in developing and maintaining the documents that support these efforts.

Many of the core concepts regulators rely on today originate from the work of the Global Harmonization Task Force (GHTF). Since the transition to IMDRF, the regulatory landscape has continued to evolve, creating a need to ensure this body of work remains current and comprehensive.

The Foundational Documents Working Group aims to define a coherent set of core documents across existing GHTF and IMDRF materials, review relevant GHTF outputs for potential updating into IMDRF publications, and assess the overall completeness of this suite by identifying and addressing gaps in key concepts.

Through this work, the Working Group seeks to establish a comprehensive and up-to-date set of IMDRF documents that can serve as a practical reference for members and stakeholders in developing their regulatory frameworks, while supporting continued global harmonisation.

Participants

Susan Barker
Therapeutic Goods Administration (TGA)

Daniel Yoon
Health Canada
Martina Buljan
Health Canada

Wenyue Zhang
National Medical Products Administration (NMPA)

Mario Cesar Muñiz Ferrer
Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) Cuba)

Katherine Alexia Funes Calderon
Sanitary Regulation Superintendency (SRS)

Chloe Spathari
European Commission
Nada Alkhayat
European Commission
Ruxandra Popescu
European Commission

Rana Chalhoub
Mecomed

Aseem Sahu
Central Drugs Standard Control Organization (CDSCO)

Diana Kanecka
Medtech (Europe)
Melissa Torres
AdvaMed

Jasjit Baveja
Medical Technology Association of Australia (MTAA)
Naoki Morooka
Shimadzu Corporation
Sunny Woo
Korean Medical Devices Industry Association (KMDIA)

Dr Madoka Murakami
Pharmaceuticals and Medical Devices Agency (PMDA)

Aseel Al Momani
Jordan Food And Drug Administration (JFDA)

Idris Idamazura
Medical Device Authority (MDA) Ministry of Health, Malaysia.

Emmanuel Armon
National Agency for Food and Drug Administration and Control (NAFDAC)

Faiza Alzadjali
Drug Safety Center (DSC)

Alison Iglesias
National Directorate of Health Surveillance (DINAVISA)

Elena Kulikova
Federal State Budgetary Institution, National Quality Institute (Roszdravnadzor)

Abdullah Alghuraibi
Saudi Food and Drug Authority (SFDA)

Gaopalelwe Kelatwang
South African Health Products Regulatory Authority (SAHPRA)

Mr Kyoung-taek Lim
Ministry of Food and Drug Safety (MFDS)
Rosa Da-yeong Ryoo (Ms)
Ministry of Food and Drug Safety (MFDS)
Young-Mee Kwon
Ministry of Food and Drug Safety (MFDS)

Gudula Sabina Mpanda
Tanzania Medicines and Medical Devices Authority (TMDA)

Dr Kenneth Cavanaugh
Food and Drug Administration (US FDA)

Azambek Sattorov
Center for Pharmaceutical Products Safety (CPPS)