Medical Device Clinical Evaluation
The purpose of the working group is to improve the effectiveness and efficiency of pre-market review by promoting increased global harmonization in approach and requirements on leveraging and evaluating the available clinical evidence, reduce the number of redundant clinical trials, integrate the principles of post-market clinical follow up and real world evidence, as applicable, and accelerate the introduction of new safe and effective medical devices/ technologies to the patients in variable jurisdictions.
The working group is developing IMDRF Technical Documents by updating the current GHTF documents on clinical evaluation which include GHTF SG5 N1, N2 and N3 documents.
Participants
Dr Simon Singer
Therapeutic Goods Administration (TGA)
Alessandro Ferreira do Nascimento
Brazilian Health Regulatory Agency (ANVISA)
Amanda Jones
Medical Devices Bureau, Health Canada
Dr Yawen Wang
Center for Medical Device Evaluation (CMDE)
Dr Yinghui Liu
Center for Medical Device Evaluation (CMDE)
Shan Ju
Center for Medical Device Evaluation (CMDE)
Gwennaelle Even
French Agency for the Safety of Health Products (ANSM)
Paul Piscoi
European Commission
Tom Melvin
Health Products Regulatory Authority (HPRA), Ireland
Bradley Matsubara
Philips
Keiichiro Ozawa
FUJIFILM Corporation
Leo Hovestadt
Elekta
Dr Theodore Lystig
Medtronic
Michael Pfleger
Alcon
Robin Newman
Johnson & Johnson Medical
Aoyagi Yumiko
Ministry of Health, Labour and Welfare (MHLW)
Dr Daisuke Fujisawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Dr Daisuke Tanaka
Ministry of Health, Labour and Welfare (MHLW)
Dr Mami Ho
Pharmaceuticals and Medical Devices Agency (PMDA)
Dr Micaela Dominguez
Pan American Health Organization (PAHO)
Kurtukov Yaroslav
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Valeeva Aisylu
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Low Lai Peng
Health Sciences Authority (HSA)
Youngmin Han
Ministry of Food and Drug Safety (MFDS)
Youngsook Choi
Ministry of Food and Drug Safety (MFDS)
Dr Minerva Hughes
Food and Drug Administration (US FDA)
Dr Soma Kalb
Food and Drug Administration (US FDA)