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
