Japan

Japan's PMDA database lists ~88,900 approved medical devices held by 2,796 MAHs; the top 50 MAHs hold 40.8%, and a 2021 cluster reflects the e-IFU/UDI mandate.

Compare medical device registration across APAC markets — China, Japan, South Korea, Australia, Singapore, India, ASEAN — including timelines, fees, reliance pathways, and strategic entry order.

When device modifications require new regulatory submissions in the US, EU, Korea, Japan, and China — FDA special 510(k), PMA supplements, EU MDR significant changes, and Asian pathways.

Japan's PMDA made eCTD v4.0 mandatory on April 1, 2026. Learn what changed, Module 1 expectations, device submission issues, and compliance steps.

Everything you need to prepare for an MDSAP audit — the 2026 updated audit approach (AU P0002.010), QMSR alignment, step-by-step preparation checklist, costs, timelines, and common nonconformities.

See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.

Guide to Japan NHI medical device procurement, covering reimbursement pricing, STM and non-STM categories, DPC bundling, hospital tendering, and foreign supplier market access requirements.

Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.

Navigate Japan's medical device approval system — PMDA pathways, QMS requirements, MAH structure, clinical trials, reimbursement, and practical market entry guidance.

Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.