Japan PMDA medical-device certifications Statistics

The Pharmaceuticals and Medical Devices Agency (PMDA) regulates medical devices in Japan. As of 2026-09-18, this official dataset snapshot contains 26,105 certificate records resolved from 26,951 official source rows at the one published certification/product/holder/succession association grain. The source does not establish current active status for these records. The dataset lists 2,129 distinct published certification holder names.

Every figure is computed from the official dataset snapshot as mirrored in the Pure Global database. Registration totals, time trends, risk classes, categories, and company rankings count each registration number once within the displayed dimension; a registration associated with multiple manufacturers may appear once under each relevant manufacturer or published country. Published company names are grouped by whitespace and case. These name counts do not establish distinct legal entities or corporate relationships. Product and category labels use the derived English value when the current row has one and otherwise preserve the official source-language value. Browse individual records in the searchable Japan device database, or see our methodology for how the data is collected.