Japan
7 articles
PMDA eCTD v4.0 for Medical Devices: Complete Transition Guide After the April 2026 Mandate
Japan's PMDA made eCTD v4.0 mandatory on April 1, 2026. This guide covers what changed, Japan-specific Module 1 requirements, medical device submission differences, and how to prepare compliant submissions.
MDSAP Audit Preparation: Complete Guide for Medical Device Manufacturers (2026)
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.
Where Does Your CE Mark Actually Get You? The Global Reliance Map for Medical Device Manufacturers
A strategic map of 25+ countries where CE marking provides regulatory leverage — organized by mechanism: full reliance, abridged review, evidence-only acceptance, and reference-only. Know which markets your CE Mark unlocks and what extra steps remain.
Japan NHI Medical Device Procurement: The Complete Guide to Reimbursement, Pricing, and Market Access
Navigate Japan's National Health Insurance system for medical devices — NHI pricing structure, STM vs. non-STM reimbursement, DPC bundling, hospital tendering, and foreign supplier requirements for the world's third-largest device market.
Medical Device Regulatory Consulting Hourly Rates by Region (2026)
Transparent benchmark of medical device regulatory consulting fees across 16 countries and regions — covering hourly rates by consultant tier, factors that drive cost, and how to budget for registration projects in the US, EU, Japan, Korea, China, India, Brazil, Saudi Arabia, and more.
Japan PMDA Medical Device Approval: The Complete Guide
Navigate Japan's medical device approval system — PMDA pathways, QMS requirements, MAH structure, clinical trials, reimbursement, and practical market entry guidance.
MDSAP Audit: The Complete Guide to the Medical Device Single Audit Program
Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.