Artificial Intelligence Medical Devices

Working Group Chair(s)
Dr Young-Kyu Kang
Ministry of Food and Drug Safety (MFDS)
South Korea
Membership
Regulators, Industry, Regional Harmonization Initiatives
Status
Current

The Charter of the Artificial Intelligence Medical Devices working group is to achieve an aligned approach to the management of artificial intelligence (AI) based-medical devices.

The first project of the working group will cover machine learning-based medical devices representing AI technology applied to medical devices and further standardize terminology for machine learning-based medical devices among member jurisdictions.

Work items

The working group has developed a document for terminology and is having the public consultation for the document below:

  • IMDRF/AIMD WG (PD1)/N67:2021 Machine Learning-enabled Medical Devices—A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions

Participants

Bioing. Carolina Magnatti
National Administration of Drugs, Food and Medical Devices (ANMAT)
Dr. José Atilio Méndez
National Administration of Drugs, Food and Medical Devices (ANMAT)

Dr David Hau
Therapeutic Goods Administration (TGA)
Leila Kalbassi
Therapeutic Goods Administration (TGA)
Mr David Wotton
Therapeutic Goods Administration (TGA)

Mr Francisco Iran Cartaxo Barbosa
Brazilian Health Regulatory Agency (ANVISA)
Mr Helio Bomfim de Macedo Filho
Brazilian Health Regulatory Agency (ANVISA)
Mr Jangley Bahia Costa
Brazilian Health Regulatory Agency (ANVISA)

Daniel Yoon
Health Canada
Janet Hendry
Health Canada

Mr Wang Chenxi
National Institute for Food and Drug Control (NIFDC), NMPA
Mr Wang Hao
National Institute for Food and Drug Control (NIFDC), NMPA
Mr Zhang Song
Center for Medical Device Evaluation (CMDE), NMPA

Mariana Madureira
National Authority of Medicines and Health Products, I.P. (INFARMED)
Nada Alkhayat
European Commission
Rolf Oberlin Hansen
Danish Medicines Agency
Steffen Buchholz
Germany Federal Ministry of Health (BMG)

Camille Vidal
GE Healthcare
Koen Cobbaert
Philips Healthcare
Naoki Morooka
Shimadzu Corporation

Mr Toshiaki Nakazato
Canon Medical Systems
Pat Baird
Philips Healthcare
Patricia Krantz-Zuppan
Medtronic

Dr Kentaro Kato
Pharmaceuticals and Medical Devices Agency (PMDA)
Mr Kuniki Imagawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Ms Yoko Tateno
Ministry of Health, Labour and Welfare (MHLW)

Vladimir Kutichev
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Dr Yow Soh Zeom
Health Sciences Authority (HSA)
Mr Lin Anle
Health Sciences Authority (HSA)

Dr Young-Woo Bae
Ministry of Food and Drug Safety (MFDS)
Mr Byeong-Nam Kim
Ministry of Food and Drug Safety (MFDS)
Mr Seung-Ho Son
Ministry of Food and Drug Safety (MFDS)
Ms Ki-Na Kim
Ministry of Food and Drug Safety (MFDS)

Johan Ordish
Medicines and Healthcare products Regulatory Agency (MHRA)
Russell Pearson
Medicines and Healthcare products Regulatory Agency (MHRA)

Matthew Diamond
Food and Drug Administration (FDA)
Shawn Forrest
Food and Drug Administration (FDA)

Anita Sands
World Health Organization (WHO)
Dr Philippe Boeuf
World Health Organization (WHO)