Intermediate2h 18m # Japan PMDA Medical Device Registration: Todokede, Ninsho, and Shonin Master Japan's Todokede, Ninsho, and Shonin pathways — and take a medical device from classification to PMDA approval without losing months to an avoidable filing mistake. Japan is the world's third-largest medical device market, and it runs on a regulatory system that looks nothing like the EU's CE marking or the FDA's 510(k) and PMA pathways. The Pharmaceutical and Medical Device Act splits every device into one of three routes — Todokede notification, Ninsho certification, or Shonin approval — and picking the wrong one, or misunderstanding what each one actually demands, is the single most common reason foreign manufacturers lose six months to a year they didn't plan for. This course takes you from first principles to complete practical compliance. You'll learn how the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) actually divide review and approval authority, how Japan's four-class, JMDN-coded classification system works, and exactly which of the three pathways applies to your device and why. You'll build a real Marketing Authorization Holder (MAH) strategy, understand Ministerial Ordinance No. 169's quality management system requirements inside and out, and walk through Foreign Manufacturer Registration, technical dossier assembly, Japanese-language labeling, and Japan's UDI system in full practical detail. By the end, you'll have a complete, defensible playbook: how to classify your device correctly, which pathway to pursue, how to appoint and manage a Marketing Authorization Holder, how to pass a QMS audit under Ordinance 169, how to assemble a Shonin submission that survives PMDA's technical review, and how to stay compliant once you're on the market. Eight downloadable tools carry that playbook into your own regulatory files, and a companion book gives you a reference you'll return to long after you finish the video. This course contains the use of artificial intelligence for asthetic purposes. * Includes the ebook edition, free * 8 downloadable resources included ## What you'll learn * 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 ## Requirements * ·No prior experience with Japanese regulatory affairs is assumed * ·Helpful (not required) to have a general familiarity with medical device risk classification from another market, such as the EU or the US * ·A specific device or device category in mind will make the worked examples more useful, but isn't required $199.00 One-time purchase · Lifetime access · No subscription Less than one hour with a compliance consultant. [First lesson free to preview: Why Japan Doesn't Use CE Marking or FDA Clearance](#lesson-2da6cc5e-2517-4204-89c1-0149ce843a00) * 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 Includes the ebook edition, free — read it in your [library](/profile/books) after purchase. Enroll — $199.00 Secure checkout via Paddle Not what you expected? Contact us within 14 days. Built from a regulatory graph already at work 1,506 users this week 661 guides 323 product types 9 markets ## Course content 146 lessons·1560 min total The Big Picture: Why Japan Runs Its Own Track 9 lessons · 70 min * Why Japan Doesn't Use CE Marking or FDA Clearance Preview7:45 * The PMDA and MHLW: Who Reviews, Who Approves 7:45 * The Three Words You'll Hear Constantly: Todokede, Ninsho, Shonin 7:45 * Why This Course Exists: The Real Cost of Getting Japan Wrong 7:45 * Japan's Position in the Global Medical Device Market 7:45 * A Quick Map of the Whole Registration Journey 7:45 * The MAH: Japan's One Non-Negotiable Requirement 7:45 * Who This Course Is For and What You'll Walk Away With 7:45 * Knowledge Check: The Big Picture 7:45 Legal Foundations: The PMD Act, PMDA, and MHLW 9 lessons · 76 min The Four Risk Classes and JMDN Classification 11 lessons · 108 min The Three Pathways: Todokede, Ninsho, and Shonin 12 lessons · 121 min Todokede: The Class I Notification Route 9 lessons · 72 min Ninsho: Certification Through Registered Certification Bodies 12 lessons · 132 min Shonin: Formal PMDA and MHLW Approval 13 lessons · 165 min The Marketing Authorization Holder (MAH) System 12 lessons · 133 min QMS Ordinance 169 and Manufacturing Site Compliance 12 lessons · 141 min Foreign Manufacturer Registration and the Application Package 10 lessons · 100 min Labeling, Japanese-Language Requirements, and UDI 12 lessons · 143 min Post-Market Surveillance, Vigilance, and Reporting 11 lessons · 119 min Common Mistakes, Full Walkthrough, and Your Action Plan 13 lessons · 181 min What's Next 1 lessons · 0 min Enroll — $199.00