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.

Session I, 15 June 2022

Agenda

Recordings

Presentations

Panel 1

The Role of BSN in the Implementation of Good Regulatory Practices, Standardization and Conformity Assessment System – Konny Sagala, BSN Indonesia

Good Regulatory Practices and Technical Barriers to Trade – Renata Amaral, MDRC Project

Panel 2

Good Regulatory Practices – Agnes Sitta Kijo, WHO

Overview Indonesia Medical Device Regulation – Lupi Trilaksono, MoH Indonesia

Session II, 22 June 2022

Agenda

Recordings

Presentations

Panel 1

Convergence in Medical Device QMS Regulation – Frédéric Hamelin, Health Canada

Indonesian Medical Device Landscape Transformation – Fikriansyah bin Irman, Ministry of Health, Indonesia

Good Regulatory Practices in Indonesia and Stakeholder’s Perspective – Randy Teguh, GAKESLAB

US FDA’s QMSR Proposed Rule Overview – Melissa Torres, US FDA

Panel 2

Post-market Surveillance for Medical Devices including IVDs – Anita Sands, WHO

Post-Market Surveillance of Medical Devices in Indonesia – Heru Sunaryo, Ministry of Health, Indonesia

An Overview of Post-Market Surveillance in Indonesia – Erwin Hermanto, ASPAKI