# International Comparison of Qualification Process for Medical Product Development Tools

## TL;DR

This paper compares qualification processes for medical product development tools in Japan versus the U.S. and Europe, finding that structured guidance policies help streamline qualification but may limit R&D support.

## Contribution

The paper introduces a lifecycle framework to analyze and compare tool qualification processes across different regulatory systems.

## Key findings

- GoG-type policies enable smoother qualification processes with consistent deliverables.
- Non-GoG policies in Japan struggle with process clarity but better support upstream R&D.
- Upstream tool integration is challenging under structured GoG-type policies.

## Abstract

Qualification of medical product evaluation tools is underway in the United States, Europe, and Japan to reflect the advancements in the basic science of medical products. In Europe and the U.S., Guidance of Guidances (GoG) policies that clarify regulators’processes, tasks, and methods of sponsor involvement are adopted to issue tool guidance. However, in Japan, a non-GoG type policy focusing on supporting the research and development for tools without defining a tool guidance-making process has been adopted.

In this study, an analytical framework for the lifecycle of development tools was constructed, including pre- and post-tool qualification processes, to compare the two above-mentioned approaches. For this study, Japanese cases were selected as experimental cases, whereas Western cases served as controls. The progress of tool qualification and composition of deliverables were analyzed.

It was indicated that in the GoG type policy, in which processes are defined, and involvement methods are clarified, tool qualification can progress more smoothly than in a non-GoG type policy. This policy indicates that deliverables may have a consistent composition. Contrastingly, GoG-type policies alone present challenges in connecting upstream tools for R&D support.