Regulatory Training on Medical Device related Standards and Guidance – Indonesia

The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed in collaboration with the Ministry of Health of Indonesia organized a training on International References and Standards on Quality Management System – MDSAP, Artificial Intelligence and Software as Medical Device (SaMD), Clinical Evaluation, Electrical Safety and Performance, and Post-market Surveillance of Medical Devices and IVDs.

Agenda

Presentations

Day 1

Quality Management System and Good Distribution Practices (Medical Devices and In Vitro Diagnostics)

ISO 13485 Certification Process/MDSAP – Billie Jo Johnson, DEKRA

Artificial Intelligence and Software as a Medical Device

Reza Pramono, Ministry of Health, Indonesia

SaMDand AI Regulatory Opportunities and Solutions – Cassie Scherer, Sr Director of Digital Health Policy & Regulatory Strategy, Medtronic

Day 2

Pre-Clinical and Clinical Test / Evaluation of Medical Devices

Alessandro Ferreira, Brazil Health Regulatory Agency (Anvisa)

Industry Highlights of IMDRF Clinical Definitions and Clinical Evaluation Process – Felicia Haynes – Medtronic

Electrical Safety and Performance for Medical Devices and IVDs

Indra Hardian Mulyadi, Senior Lecturer, Batam State Polytechnic

Post Market Surveillance of Medical Devices and IVDs

Post Market Surveillance of Medical Devices and IVDs – Adrien Inoubli, WHO South-East Asia Regional Office

International Best Practices and Innovations in Adverse Event Reporting – Tanuj Shukla and Tammy Steuerwald, Roche Diagnostics