E-Book22 chapters # Japan PMDA Medical Device Registration Handbook A Japan medical device handbook: the PMD Act, risk classes and JMDN, the Todokede, Ninsho and Shonin pathways, registered certification bodies and PMDA. Japan is the world's third-largest medical device market, and it runs on a regulatory system built around three words that don't translate cleanly into English: Todokede, Ninsho, and Shonin. This book is a complete, standalone reference for understanding and navigating that system — from the legal foundations of the Pharmaceutical and Medical Device Act, through Japan's four-class, JMDN-coded classification system, to the practical mechanics of choosing a pathway, appointing a Marketing Authorization Holder, passing a quality management system audit under Ministerial Ordinance No. 169, and managing post-market vigilance once your device is on the market. Written for regulatory affairs professionals, consultants, and manufacturers bringing a device into Japan for the first time, this book takes the same first-principles-to-practical approach as the companion course, organized so you can read it start to finish or use it as a working reference once your own project is underway. Eight appendices document the downloadable tools that accompany this material, and a full action plan closes the book with a concrete starting sequence for your own Japan market entry. ## What you'll learn * Understand how the PMD Act, the PMDA, and the MHLW divide regulatory authority in Japan * Classify any medical device correctly using Japan's four-class, JMDN-coded system * Know exactly which of Todokede, Ninsho, or Shonin applies to your device, and why * Build a compliant Marketing Authorization Holder (MAH) strategy for a foreign manufacturer * Pass a QMS audit under Ministerial Ordinance No. 169 * Assemble a Foreign Manufacturer Registration application and a full technical dossier * Meet Japan's Japanese-language labeling, package insert, and UDI requirements * Manage post-market vigilance, adverse event reporting, and change control after approval $34.99 One-time purchase · Read in browser · No subscription * Understand how the PMD Act, the PMDA, and the MHLW divide regulatory authority in Japan * Classify any medical device correctly using Japan's four-class, JMDN-coded system * Know exactly which of Todokede, Ninsho, or Shonin applies to your device, and why Buy for $34.99 Secure checkout via Paddle Not what you expected? Contact us within 14 days. This book is included free when you enroll in the full course — [$199.00 for the complete video curriculum plus this book](/courses/59-japan-pmda-medical-device-registration). Built from a regulatory graph already at work 2,191 users this week 658 guides 323 product types 9 markets ## Chapters Read Chapter 1 free → 1 The Big Picture: Why Japan Runs Its Own Track Japan's medical device framework can feel opaque from the outside, built around terminology — Todokede, Ninsho, Shonin — that has no direct English equivalent. 2 Legal Foundations: The PMD Act, PMDA, and MHLW Every rule in this book traces back to one statute. 3 The Four Risk Classes and JMDN Classification Classification in Japan is a two-part determination: a risk class, and a specific generic name code from the Japan Medical Device Nomenclature system. 4 The Three Pathways: Todokede, Ninsho, and Shonin With classification established, this chapter builds out the full decision logic for choosing between Japan's three registration pathways — and the single fa… 5 Todokede: The Class I Notification Route The fastest of the three pathways is also the one most often mishandled by assumption. 6 Ninsho: Certification Through Registered Certification Bodies Ninsho puts a private, MHLW-accredited certification body between you and the market. 7 Shonin: Formal PMDA and MHLW Approval Every device without a lighter option lands here — every Class IV device, and every Class II or Class III device without a matching standard. 8 The Marketing Authorization Holder (MAH) System No device reaches the Japanese market without a Japan-based Marketing Authorization Holder — this chapter is a complete reference for that relationship, from… 9 QMS Ordinance 169 and Manufacturing Site Compliance Japan wants confidence that your manufacturing process will keep producing safe, effective devices indefinitely, not just that your first unit passed testing. 10 Foreign Manufacturer Registration and the Application Package Before any notification, certification, or approval filing can proceed, every overseas manufacturing site needs Foreign Manufacturer Registration. 11 Labeling, Japanese-Language Requirements, and UDI A device can clear every other stage of this process and still stall at the last step over labeling. 12 Post-Market Surveillance, Vigilance, and Reporting Approval is not a finish line. 13 Common Mistakes, Full Walkthrough, and Your Action Plan This closing chapter traces one realistic device from classification through launch, applying every principle covered earlier in the book, and closes with a … 14 Knowledge Checks Every module in this book includes a short knowledge check in the course itself. 15 Appendix A: Device Classification & JMDN Code Finder Worksheet 16 Appendix B: Pathway Decision Tool 17 Appendix C: MAH Selection & Due Diligence Checklist 18 Appendix D: QMS Ordinance 169 Readiness Audit 19 Appendix E: Foreign Manufacturer Registration Application Tracker 20 Appendix F: Shonin Technical Dossier Completeness Checklist 21 Appendix G: Japanese Labeling & UDI Compliance Checklist 22 Appendix H: Post-Market Vigilance & Reporting Timeline Planner Buy for $34.99 ## Want the full video course? This book's companion course covers the same material with video lessons and downloadable resources — and includes this book free. [ ![Japan PMDA Medical Device Registration Course](/posters/59-japan-pmda-medical-device-registration.svg) ](/courses/59-japan-pmda-medical-device-registration) Intermediate2h 18m [ ### Japan PMDA Medical Device Registration Course ](/courses/59-japan-pmda-medical-device-registration) Register medical devices in Japan: PMD Act classes, JMDN codes, Todokede, Ninsho and Shonin pathways, PMDA review, the MAH role and QMS requirements. Includes the ebook, free $199.00[View course →](/courses/59-japan-pmda-medical-device-registration) Need more than one? The **All-Access Krono Vault** unlocks every course and book for one payment, or put your whole team on it with **Krono Team Vault**. [See pricing](/pricing) Short on time? ### Rather hand it over than learn it? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. [See services](/services)