2026
IMDRF Training on GHTF N78: Principles of Conformity Assessment of Medical Devices and IMDRF/GRRP WG/N89: Playbook for Medical Device Regulatory Reliance Programs – September 13, 2026
In September 13th in Singapore, regulatory authorities and industry experts gathered for the IMDRF Training Session on GHTF N78: Principles of Conformity Assessment of Medical Devices and IMDRF/GRRP WG/N89: Playbook for Medical Device Regulatory Reliance Programs.
Featuring interactive presentations, group exercises, and practical case studies led by international regulatory agencies and industry stakeholders—including the US FDA, HSA, TGA, PMDA, ANVISA, and the WHO—the session promoted global harmonization and collaborative learning. The event demonstrated broad international engagement, welcoming in-person and virtual participants across 19 countries in Latin America, Asia, Africa, and the Pacific.
Agenda and Presentations are available here in english language.
The recording is available here in english language.
2024
IMDRF Training on Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N47)
On 11 and 19 September, 2024, the International Medical Device Regulators Forum (IMDRF) organized a two-part workshop focused on building Medical Device National Regulatory Authority (NRA) capacities and awareness of the IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, for current and prospective IMDRF Affiliate Members. This two-part workshop took place in conjunction with the U.S. Food and Drug Administration (USFDA) hosting of the IMDRF meetings.
The workshop was led by representatives of the NRA member bodies of the IMDRF Management Committee joined by select medical device industry representatives to provide real-world perspectives of the application and benefits of the Essential Principles as a cornerstone of effective medical device regulatory frameworks. This workshop is meant to serve as an introductory overview of the topics upon which future IMDRF training sessions may expand.
The Training Objectives for the workshop are as follows:
- Emphasize the importance of the IMDRF Essential Principles as a foundational reference for NRA Medical Device Regulatory Frameworks – underpinning all other IMDRF documents.
- Relay how NRA prioritized use of the Essential Principles enables the establishment of the proper legal foundations for medical device rulemaking by serving as a core tool to implement Good Regulatory Practices (GRP).
- Overview how the Essential Principles as GRP promote and facilitate the use of relevant international standards and conformity assessment as core components of GRP and proper legal foundations, accelerating medical device regulatory convergence.
- Engage in a group activity applying Essential Principles to specific medical devices.
- Review a case study in the real-world application of the Essential Principles.
The recordings and materials shared during the sessions are available via the following links: