Conformity Assessment (N78) and Reliance Playbook (N89)
On 13 September 2026, the IMDRF organized a two-part workshop focused on developing understanding of the IMDRF guidance documents N78 (GHTF): Conformity Assessment and N89: Reliance Playbook. This two-part workshop was delivered by industry and regulator representatives and took place in conjunction with the Singapore Health Services Agency's (HSA) hosting of the IMDRF meetings.
This training explored internationally recognized principles of conformity assessment and regulatory reliance that support regulatory cooperation, information sharing, efficiency, and timely patient access to safe, effective, and high-quality medical devices and IVDs.
The training slideshow is attached below. A link to the recording of the session will be made available from this page in the near future