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[New Medical Device Evaluation].

¹Clinical Research, Innovation and Education Center, Tohoku University Hospital.

Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan

|April 5, 2016

Summary

This summary is machine-generated.

The Harmonization by Doing project successfully reduced medical device lags in Japan by fostering international collaboration. This initiative streamlined global clinical trials, improving patient access to innovative medical devices.

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Area of Science:

Regulatory Science
Medical Device Development
International Collaboration

Background:

Japan historically lagged in adopting innovative medical therapeutic devices due to limited domestic development and export.
A significant device lag resulted in restricted patient access to advanced medical treatments in Japan.

Purpose of the Study:

To discuss the significance of regulatory science in global medical device development.
To share experiences from the Harmonization by Doing (HBD) project in international collaboration for medical devices.
To highlight Japan's efforts in promoting global clinical trials and reducing device lag.

Main Methods:

The Harmonization by Doing (HBD) project involved stakeholders from academia, regulatory authorities, and industry in the US and Japan.
Identifying and addressing challenges in conducting medical device clinical trials in Japan.
Promoting the acceptance of foreign clinical trial data and conducting global clinical trials.

Main Results:

Over 10 years, Japan has become a key participant in global clinical trials, enabling timely approvals.
The HBD project successfully reduced the lag in medical device availability.
Initiated international convergence efforts for medical device regulatory science.

Conclusions:

International collaboration through projects like HBD is crucial for advancing global medical device development.
Active participation in global clinical trials and regulatory harmonization accelerates patient access to innovative devices.
Future efforts will focus on international convergence, with physicians and regulatory authorities leading guideline development for clinical evaluation.