Regulatory Training on Medical Device related Standards and Guidance – Indonesia, 8 – 9 September, 2022
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.
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
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
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.