Medical Devices

The goals of the Roadmap for Medical Device PWA are to promote international harmonization initiatives, build regulatory capacity and knowledge, and support harmonized implementation efforts among member economies of the Asia Pacific Economic Cooperation (APEC). To reach the goals, CoEs are providing training programs so as to disseminate International Medical Device Regulators Forum (IMDRF) and former Global Harmonization Task Force (GHTF) Guidance Documents.

CHAMPIONS

  • Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Ministry of Food and Drug Safety (MFDS), Korea
  • US Food and Drug Administration (US FDA), United States

SUB-CHAMPIONS

  • Japan Medical Imaging and Radiological Systems Industries Association (JIRA), Japan
  • Advanced Medical Technology Association (AdvaMed), United States

CENTERS OF EXCELLENCE

  • Sichuan University (SCU), China 
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • National Institute of Medical Device Safety Information (NIDS), Korea
  • Soonchunhyang University (SCH), Korea
  • Taiwan Food and Drug Administration (TFDA), Chinese Taipei
  • University of Southern California (USC), United States

PILOT CENTERS OF EXCELLENCE

  • Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore
  • Northeastern University (NEU), United States

ACTIVITIES

2021

APR

APEC CoE Training (Virtual)

University of Southern California (USC), United States

2020

DEC

APEC Centers of Excellence Established

Soonchunhyang University (SCH), Korea

NOV

APEC CoE Training (Virtual)

National Institute of Medical Device Safety Information (NIDS), Korea

NOV

APEC CoE Training (Virtual)

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

OCT-NOV

APEC Pilot CoE Training (Virtual)

Soonchunhyang University (SCH), Korea

AUG-SEP

APEC CoE Training (Virtual)

Taiwan Food and Drug Administration (TFDA), Chinese Taipei

JUN

APEC Centers of Excellence Established

Sichuan University (SCU), China

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Taiwan Food and Drug Administration (TFDA), Chinese Taipei

APEC Pilot Center of Excellence established

Soonchunhyang University (SCH), Korea

Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore

2019

DEC

APEC Pilot CoE Training (China)

Sichuan University (SCU), China

NOV

APEC CoE Training (Korea)

National Institute of Medical Device Safety Information (NIDS), Korea

APEC Pilot CoE Training (Japan)

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

OCT

APEC Pilot CoE Training (Chinese Taipei)

Taiwan Food and Drug Administration (TFDA), Chinese Taipei

AUG

APEC Centers of Excellence Established

National Institute of Medical Device Safety Information (NIDS), Korea

 

University of Southern California (USC), United States

APEC Pilot Center of Excellence established

Sichuan University (SCU), China

APR

APEC Pilot CoE Training (United States)

University of Southern California (USC), United States

MAR

APEC Pilot Center of Excellence established

Taiwan Food and Drug Administration (TFDA), Chinese Taipei

FEB

APEC Pilot Centers of Excellence established

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

 

Northeastern University (NEU), United States

 

University of Southern California (USC), United States

2018

SEP

APEC Pilot CoE Training (Korea)

APEC Harmonization Center (AHC) – National Institute of Medical Device Safety Information (NIDS), Korea