[Home](/)/[Resources](/resources)/Japan Medical Device Registration JapanGlobalRegulation guide # Japan Medical Device Registration Japan's Pharmaceutical and Medical Device Act routes devices through one of three tiers based on risk classification — Todokede notification for Class I, Ninsho third-party certification for Class II, and Shonin PMDA approval for Class III/IV. Foreign manufacturers additionally need a Designated Marketing Authorization Holder (DMAH) as their Japan-based regulatory representative before any of the three routes can be completed. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fjapan-medical-device-registration) At a glance Regulator MHLW / PMDA Class I route Todokede (notification) Class III/IV route Shonin (PMDA approval) Foreign manufacturers DMAH required ## The three registration routes ### Todokede (notification) — Class I The lightest route: low-risk devices require notification only, with no pre-market review by PMDA. Examples include bandages and non-powered wheelchairs. ### Ninsho (certification) — Class II Medium-risk devices require certification by a registered third-party certification body rather than direct PMDA review — a structural parallel to how Japan handles diamond-PSE electrical products, though administered under the separate PMD Act. ### Shonin (approval) — Class III/IV High-risk devices require full PMDA review and approval, with clinical data requirements for higher-risk and genuinely novel devices. This is the most demanding route, comparable in rigor to a US PMA or an EU MDR Class III conformity assessment. ### IVDs have their own classification logic In-vitro diagnostics follow separate classification rules from general medical devices — infectious disease tests, in particular, often land in a higher class than a device with superficially similar risk might suggest. ## Structural requirements for foreign manufacturers 01 Foreign manufacturers must register before their device can be marketed in Japan — this registration requirement is independent of the device's own classification route. 02 A Designated Marketing Authorization Holder (DMAH) is required for foreign manufacturer market access — the DMAH is the Japan-based entity taking on regulatory responsibility, similar in function to an EU Authorised Representative. 03 A Master File system lets component suppliers submit confidential technical information directly, without requiring the device manufacturer to have full visibility into proprietary supplier data — useful for complex, multi-supplier devices. 04 Clinical data requirements scale with risk: expected for Class III/IV and genuinely novel devices, generally not required for Todokede-route Class I notifications. ## Frequently asked questions ### What's the practical difference between Ninsho and Shonin? Ninsho (Class II) routes through a registered third-party certification body — faster and less resource-intensive than direct government review. Shonin (Class III/IV) requires direct PMDA review and approval, typically with clinical data requirements, and is the more demanding, higher-scrutiny pathway reserved for higher-risk devices. ### Do I need a DMAH even if I have a Japanese distributor? A distributor relationship alone doesn't satisfy the DMAH requirement. The Designated Marketing Authorization Holder is a specific regulatory role carrying legal responsibility for the device's compliance in Japan — a distributor and a DMAH can be the same entity, but the DMAH designation itself is a distinct regulatory status, not implied by a general commercial distribution agreement. ### How does the Master File system help component suppliers? It lets a component or subsystem supplier submit proprietary technical data directly to PMDA under confidentiality, referenced by the device manufacturer's application without requiring the manufacturer to hold or disclose that confidential data themselves — useful when a device integrates components from multiple specialized suppliers. ### Are IVDs always higher-risk than comparable general medical devices? Not universally, but IVD classification follows its own logic separate from general devices, and infectious disease tests in particular often land in a higher risk class than their apparent complexity might suggest — don't assume an IVD maps directly onto the same class as a general device with similar technical characteristics. **Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions. 🇯🇵 Japan roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇯🇵 Japan compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $199](/courses/59-japan-pmda-medical-device-registration)[Prefer to read? Get the book — $34.99](/books/59-japan-pmda-medical-device-registration) Related guides * [Japan Compliance OverviewJapan's multi-agency compliance framework: PSE electrical safety, radio certification, medical devices, and consumer safety.](/guides/japan-compliance-overview) * [Hong Kong Medical Device ListingMDACS voluntary listing today, and Hong Kong's 2026 statutory registration transition with the new CMPR.](/guides/hong-kong-medical-device-listing) * [Canada Medical Device LicensingHealth Canada's Class I-IV medical device licensing, ISO 13485 requirements, and the public MDALL registry.](/guides/canada-medical-device-licensing) * [Australia TGA Medical Device RegistrationTGA's Class I through III and AIMD classification, conformity assessment routes, and ARTG inclusion.](/guides/australia-tga-medical-device-registration)