APEC Center of Excellence Medical Device

Agenda

2025 GHC–SCH APEC CoE Collaborative Training on Medical Device TPLC Lecture List
September 4^th – October 31^th 2025 I Online Training

Method	Time	Topic	Core Curriculums	Speaker

Subject 1: Medical Devices (5.6 hr course)

Objective: 1) To understand the requirement of clinical evaluation for medical devices based on IMDRF guidance 2) To share the best practices in the clinical investigation of medical devices 3) To understand harmonized approach to the classification of medical devices based on GHTF guidance
VOD Lectures	60 mins	Part 1. Essential Principles of Safety and Performance: Medical Devices Part 2. Using Essential Principles of Safety and Performance in Medical Device Development	Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N047: FINAL: 2024 Edition 2)	Frances Richmond, University of Southern California
	40 mins	Classification of Medical Devices	Principles of Medical Devices Classification (GHTF/SG1/ N77:2012)	Naoki Morooka, JIRA
	40 mins	Medical Device Adverse Event Terminology	IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) (IMDRF/AE WG/N43FINAL:2020) with IMDRF code: IMDRF/AE WG/N43FINAL:2025 Updated Annexes (Release No. 2025)	Ishikawa Hiroshi, University of Yamanashi
	40 mins	Best Practice for Medical Devices Adverse Event Monitoring	IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) (IMDRF/AE WG/N43FINAL:2020) with IMDRF code: IMDRF/AE WG/N43FINAL:2025 Updated Annexes (Release No. 2025)	Kichang Nam, Dongguk University
	40 mins	Adverse Event Investigation Process	Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices (GHTF/SG2/N54R8:2006)	Eric Woo, ECRI
	40 mins	Adverse Event Reporting Process	Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices (GHTF/SG2/N54R8:2006)	Nur Hazreen Abdul Razak, Medical Device Authority Malaysia
	40 mins	ISO 13485 Fundamentals: A Practical Approach to Medical Device Audits	ISO13485: 2016 Medical devices - Quality management systems - Requirements for Regulatory Purposes	Hyeonho Kim, Samsung Medison
	40 mins	Risk Management and ISO 14971 with focus on practical implementation	ISO 14971: 2019 Medical Devices - Application of Risk Management for Medical Devices	Jos van Vroonhoven, Philips, ISO/TC 210 JWG 1 Convenor
Hands-on 1	IMDRF terminologies for medical device adverse event		IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) (IMDRF/AE WG/N43FINAL:2020) with IMDRF code: IMDRF/AE WG/N43FINAL:2025 Updated Annexes (Release No. 2025)	Soe Ye Yint Tun, SCH APEC CoE

Subject 2: IVD Medical Devices (2 hr course)

Objectives: 1) To understand the essential principles of Safety and Performance of IVD medical devices 2) To understand harmonized approach to the classification of IVD medical devices based on GHTF guidance
VOD Lectures	40 mins	Safety and Performance of In Vitro Diagnostic Medical Devices	Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N047: FINAL: 2024 Edition 2) Clinical Evidence for IVD Medical Devices-Clinical Performance studies for IVDs (GHTF/SG5/N8:2012)	You Kyoung Lee, SCH APEC CoE
	40 mins	Classification of IVD medical devices	Principles of IVD Medical Devices Classification (IMDRF/IVD WG/ N64 FINAL: 2021 formerly GHTF/SG1/N045:2008)	Hwan Sub Lim, Seoul Clinical Laboratories
	40 mins	Clinical Evidence of IVD Medical Devices	Clinical Evidence for IVD Medical Devices-Key Definitions and Concepts (GHTF/SG5/N6:2012) Clinical Evidence for IVD Medical Devices-Scientific validity determination and Performance Evaluation (GHTF/SG5/N7:2012) Clinical Evidence for IVD Medical Devices-Clinical Performance studies for IVDs (GHTF/SG5/N8:2012)	Nurizzati Bt Haris Fadzilah, Medical Device Authority Malaysia
Hands-on 2	Classification of IVD medical devices		Principles of IVD Medical Devices Classification (IMDRF/IVD WG/ N64 FINAL: 2021 formerly GHTF/SG1/N045:2008)	Soe Ye Yint Tun, SCH APEC CoE

Untact Conferences (3 hr course)

Untact Conferences	60 mins	Live Video Conference 1 (September 4^th, 2025, 09:00AM KST) • Opening and Introduction of SCH CoE • How to participate in the 2025 SCH APEC MD CoE Training		SCH APEC CoE
	120 mins	Live Video Conference 2 (October 17^th, 2025, 09:00AM KST) Best Practice Series for Clinical Investigation • Emerging Issues and Techniques for Clinical Investigation • Closing the 2024 training	Clinical Investigation (IMDRF MDCE WG/N57FINAL:2019)	Jaesoon Choi, Ulsan University
	120 mins	Live Video Conference 2 (October 17^th, 2025, 09:00AM KST) Best Practice Series for Clinical Investigation • Q & A session for each lecture		Moderator C. Benson Kuo, University of Southern California

This year’s training is exclusively online. Participants can engage with the speakers during the Untact Conferences. For a more effective learning experience, we recommend attending both Untact Conferences.