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TGA ยท 7 resources

Every free medical device regulatory resource currently available for Japan, organized into one maintained country hub.
Open a resource directly, or use the medical device hub for a market-level overview.
Search official PMDA device registration records.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official PMDA regulations and guidance documents.
Compare official and realistic approval times by device class and pathway.
Review current PMDA application, review, and renewal fees.
Follow recent PMDA policy, guidance, and compliance updates.
Describe your device and get a preliminary PMDA risk class with an explanation and source links.