SaMD is software used for treatment, diagnosis and prevention of disease. This flow chart describes development and regulatory application processes in Japan.
*Pharmaceuticals and Medical Devices Agency
✓The need of clinical data greatly affects the time/budget required for development.
✓Micron can propose the optimal and shortest process.
Micron offers a full range of services for obtaining certification/approval of SaMD, including consultation, study planning and operation, and handling of PMDA approval applications.
Please feel free to contact us for more information.
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This article was written on 27 Jun 2022.