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.
CO-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
The PWA Co-Champions and Sub-Champions’ contacts can be found here.
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
The respective Centers of Excellence’s contacts and website links can be found here.
ACTIVITIES
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2021 |
NOV |
APEC CoE Training (Virtual) |
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Pharmaceuticals and Medical Devices Agency (PMDA), Japan |
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SEP |
APEC CoE Training (Virtual) |
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Soonchunhyang University (SCH), Korea |
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AUG-SEP |
APEC CoE Training (Virtual) |
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Taiwan Food and Drug Administration (TFDA), Chinese Taipei |
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MAY |
APEC CoE Training (Virtual) |
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Sichuan University (SCU), China |
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APR |
APEC CoE Training (Virtual) |
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University of Southern California (USC), United States |
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2020 |
DEC |
APEC Centers of Excellence Established |
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Soonchunhyang University (SCH), Korea |
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NOV |
APEC CoE Training (Virtual) |
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National Institute of Medical Device Safety Information (NIDS), Korea |
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NOV |
APEC CoE Training (Virtual) |
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Pharmaceuticals and Medical Devices Agency (PMDA), Japan |
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OCT-NOV |
APEC Pilot CoE Training (Virtual) |
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Soonchunhyang University (SCH), Korea |
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AUG-SEP |
APEC CoE Training (Virtual) |
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Taiwan Food and Drug Administration (TFDA), Chinese Taipei |
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JUN |
APEC Centers of Excellence Established |
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Sichuan University (SCU), China |
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Pharmaceuticals and Medical Devices Agency (PMDA), Japan |
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Taiwan Food and Drug Administration (TFDA), Chinese Taipei |
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APEC Pilot Center of Excellence established |
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Soonchunhyang University (SCH), Korea |
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Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore |
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2019 |
DEC |
APEC Pilot CoE Training (China) |
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Sichuan University (SCU), China |
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NOV |
APEC CoE Training (Korea) |
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National Institute of Medical Device Safety Information (NIDS), Korea |
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APEC Pilot CoE Training (Japan) |
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Pharmaceuticals and Medical Devices Agency (PMDA), Japan |
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OCT |
APEC Pilot CoE Training (Chinese Taipei) |
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Taiwan Food and Drug Administration (TFDA), Chinese Taipei |
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AUG |
APEC Centers of Excellence Established |
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National Institute of Medical Device Safety Information (NIDS), Korea |
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University of Southern California (USC), United States |
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APEC Pilot Center of Excellence established |
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Sichuan University (SCU), China |
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APR |
APEC Pilot CoE Training (United States) |
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University of Southern California (USC), United States |
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MAR |
APEC Pilot Center of Excellence established |
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Taiwan Food and Drug Administration (TFDA), Chinese Taipei |
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FEB |
APEC Pilot Centers of Excellence established |
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Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Northeastern University (NEU), United States
University of Southern California (USC), United States |
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2018 |
SEP |
APEC Pilot CoE Training (Korea) |
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APEC Harmonization Center (AHC) – National Institute of Medical Device Safety Information (NIDS), Korea |