Overview
PMDA conducts scientific review of imaging devices and radiopharmaceuticals and coordinates clinical trial oversight in Japan.
Modality Relevance
Reviews cover CT MRI PET SPECT ultrasound and hybrid imaging systems with local technical requirements.
International Cooperation
PMDA engages in global regulatory harmonization and reliance initiatives for imaging products.
Clinical Effect
PMDA approvals enable access to imaging technologies and tracers in the Japanese market.