2024 SCH APEC Medical Device CoE Training
Online : October 8^th - 31^st , 2024

• Design training programs that meet PWA CoE Program Committee’s training objectives in the scope of Total Product Life Cycle of Medical Devices
• Deliver training programs effectively and promote harmonization and advancement of the use of standards in the assessment of medical devices among APEC region
• Assess the implementation and outcomes of CoE training and provide suggestions for future regulatory harmonization activities APEC LSIF RHSC
• Secure programs and a pool of lecturers and experts to disseminate the importance of the use of standards

The 2024 SCH APEC Medical Device CoE Training endeavors to train and educate ourselves on the topics across the total product life cycle of medical devices. The two main subject areas are Medical Devices and IVD medical devices. Through this training, we expect to expand the understanding of international standards, harmonize the regulatory systems for medical devices within APEC economies, build reliability on clinical tests conducted for medical devices, and thereby, share the benefits from the development of medical devices and healthcare within APEC economies.

• Regulators from APEC economies
• A wider range of stakeholders including academia, industry, etc

The training will be held virtually at SCH website with pre-recorded lecture videos, hands-on exercises and untact conference

• Certificates of participation will be issued to qualified trainees that have met the following minimum requirements:

  • Complete watching 6 or more VOD lectures
  • Practice at least 4 online activities of Hands-on 1 (IMDRF adverse event terminology)
  • Practice at least 6 online activities of Hands-on 2 (Classification of IVD Medical Devices)
  • Attend one or both Untact Conferences
  • Completion of the Satisfaction Survey