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

Session I

Recording

Quality Management System – MDSAP

Billie Jo Johnson, DEKRA

Artificial Intelligence and Software as a Medical Device

Reza Pramono, Ministry of Health, Indonesia

Cassie Scherer, Medtronic and Diane Johnson, Johnson & Johnson MedTech

Session II

Recording

Clinical Evaluation of Medical Devices

Alessandro Ferreira, Brazil Health Regulatory Agency (Anvisa)

Felicia Haynes, Medtronic

Electrical Safety and Performance for Medical Devices and IVDs

Indra Hardian Mulyadi, Batam State Polytechnic

Post Market Surveillance of Medical Devices and IVDs

Adrien Inoubli, WHO South-East Asia Regional Office

Tanuj Shukla and Tammy Steuerwald, Roche Diagnostics

Webinar on Good Regulatory Practices and Medical Device Regulation in Indonesia

The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed in collaboration with the Ministry of Health of Indonesia and Gadjah Mada University organized a Webinar series on Good Regulatory Practices, focused on the World Trade Organization’s (WTO) Technical Barriers to Trade (TBT) agreement and legal obligations as it relates to GRPs and Indonesia’s national commitments, global frameworks for medical device regulations, and best practices on management of safety and efficacy of medical devices.