Regulatory Readiness for Medical Devices in Japan
Japan is a mature, high-compliance medical-device market overseen by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW).
In Short
- Japan’s device regime is set by the PMD Act (Yakuji Hou).
- Japan classifies devices I–IV by risk.
- Routes: (a) Class I: Todokede (notification) by the MAH/D‑MAH prior to marketing; (b) Class II Designated Controlled: Ninsho via an RCB (e.g., BSI Group Japan K.K.,…
The Pharmaceutical and Medical Device Act (PMD Act, Yakuji Hou) governs classification, market authorization, QMS, UDI, and post-market duties. Unique features include the need for a Japan-based Marketing Authorization Holder (MAH or Designated MAH, DMAH), foreign manufacturer registration, Japan’s QMS Ordinance (MHLW Ordinance No. 169) aligned with ISO 13485, and vigilance under the GVP Ordinance. This guide details classification, approval routes (Todokede/Ninsho/Shounin), Registered Certification Bodies (RCB) use, change controls, labeling and language, and a concrete 90–180 day readiness plan.
1) The regulator and legal framework
Japan’s device regime is set by the PMD Act (Yakuji Hou). The most recent major amendment was passed in 2019 and fully enforced from 2021, strengthening UDI, SaMD oversight, PMS and change control.
More on 1) The regulator and legal framework
PMDA conducts scientific reviews and inspections; MHLW issues approvals and ordinances. Key subordinate regulations: QMS Ordinance (MHLW Ordinance No. 169; originally 2004, substantially harmonized with ISO 13485 and updated through 2021–2024), and the GVP Ordinance for post‑market safety management (MHLW Ordinance No. 135 of 2004, updated periodically). A Japanese entity must hold the marketing authorization as MAH; foreign manufacturers typically appoint a D‑MAH to hold Shounin (approval), Ninsho (certification), or Todokede (notification). Foreign manufacturing sites require foreign manufacturer registration/accreditation under the PMD Act. Japan adopts many JIS versions of international standards and maintains the JMDN (Japanese Medical Device Nomenclature) database, which drives classification and dossier structure.
2) Device classification in Japan
Japan classifies devices I–IV by risk. Class I (General) typically requires only notification (Todokede).
More on 2) Device classification in Japan
Class II (Controlled) devices may be designated for third‑party certification; such “Designated Controlled” devices follow Ninsho via a Registered Certification Body (RCB). Non‑designated Class II and most Class III/IV (Specially Controlled) devices require PMDA scientific review and MHLW approval (Shounin). Classification and the applicable route hinge on the JMDN code assignment; PMDA maintains a public JMDN search to determine code and designated status. Software as a Medical Device (SaMD) is classified per function and clinical impact; post‑2021 amendments clarified change control and continuous update management for SaMD. Active implantables and novel technologies generally fall into Class III/IV and undergo full PMDA review. Using recognized JIS/IEC standards (e.g., JIS T 0601‑1 for IEC 60601‑1) can streamline review and RCB interactions.
3) Conformity assessment and approval pathways
Routes: (a) Class I: Todokede (notification) by the MAH/D‑MAH prior to marketing; (b) Class II Designated Controlled: Ninsho via an RCB (e.g., BSI Group Japan K.K., TÜV Rheinland Japan, JQA), based on a technical dossier aligned to STED with recognized JIS test reports; (c) Other Class II and all Class III/IV: Shounin approval following PMDA scientific review, with possible pre‑submission consultation. All submissions are in Japanese.
More on 3) Conformity assessment and approval pathways
Technical files cover safety/effectiveness, clinical evaluation (or clinical trial data under Japan GCP when needed), biocompatibility, electrical safety/EMC, software lifecycle and cybersecurity, sterilization/packaging, and risk management per JIS Q 14971. PMDA or the RCB also conducts QMS conformity inspection tied to the product scope and manufacturing sites. Change control uses Partial Change Approval (Ichibu Henkou Shounin) for significant design/indication/manufacturing changes, and Minor Change Notification (Keibi Henkou Todokede) for limited updates; RCB‑certified devices follow equivalent change pathways with their RCB.
4) QMS expectations and mapping to ISO 13485
MHLW Ordinance No. 169 harmonizes with ISO 13485 but adds Japan‑specific elements.
More on 4) QMS expectations and mapping to ISO 13485
QMS conformity inspections are site‑ and product‑scope specific and may be on‑site or document-based. Japan participates in MDSAP; PMDA/MHLW accept MDSAP audit reports to reduce or substitute QMS inspections where applicable, but national differences and product‑specific evidence are still required. MAH/D‑MAH responsibilities include maintenance of post‑market safety management under GVP, oversight of distributors/importers, and robust supplier controls. Required documentation mirrors ISO 13485: design controls, production/process controls, purchasing, installation/servicing (if applicable), complaint handling, vigilance, CAPA, and internal audits. For SaMD, lifecycle documentation (IEC 62304), usability (JIS T 62366‑1), and cybersecurity guidance are expected in both product and QMS processes. All quality records relevant to the Japan product scope must be accessible in Japanese or accompanied by accurate translations.
5) UDI, labeling, and Japanese-language requirements
Under PMD Act amendments enforced from 2021, Japan requires unique device identification on labels and packaging, using accepted carriers (GS1, HIBCC, ICCBBA as applicable). UDI must be consistent with authorization details and traceable to the MAH.
More on 5) UDI, labeling, and Japanese-language requirements
Labeling and IFU must be in Japanese and include: device name/model, intended use, MAH name/address/phone, manufacturer, country of origin (if imported), lot/serial/UDI, storage/expiry (if applicable), sterility, warnings/precautions, and JMDN code reference in submissions. Reusable devices needing direct part marking must carry the UDI-DI/PI as technically feasible. E‑labeling is permitted for certain device types under MHLW notifications; however, a Japanese-language IFU must be available to users. Claims must align strictly with the approved Shounin/Ninsho/Todokede content; discrepancies trigger deficiency letters or recalls. Consistency across packaging levels and promotional materials is scrutinized by PMDA and local authorities.
6) Post-market surveillance, vigilance, and adverse-event reporting
The GVP Ordinance mandates that the MAH maintain a PMS system, including complaint handling, adverse event/malfunction evaluation, trending, field safety corrective actions (recalls), and post‑market clinical follow‑up when needed. Reportable events must be submitted to PMDA within statutory timelines: deaths or life‑threatening events generally within 15 calendar days; other serious reportable events/malfunctions typically within 30 days; foreign serious cases may also be reportable if relevant to Japan usage.
More on 6) Post-market surveillance, vigilance, and adverse-event reporting
Recalls/classifications and corrective actions must be notified promptly to authorities and publicly posted through the government recall channels. Periodic safety reports may be required for certain higher‑risk devices or as a condition of approval. The MAH must ensure distributor/importer feedback is captured, evaluated, and fed into CAPA. For SaMD operating on continuous deployment, update management and field performance monitoring are expected and tied to change control and risk management.
7) A 90–180 day readiness plan for Japan entry
- Days 0–30
Confirm JMDN code and risk class; decide Ninsho vs Shounin pathway; select/contract a Japan D‑MAH (if you won’t establish your own MAH); initiate foreign manufacturer registration; compile recognized JIS/IEC test evidence; gap‑assess QMS to Ordinance 169 (and MDSAP acceptance if available); define labeling/UDI strategy and Japanese translation plan.
- Days 31–90
Build STED‑like technical file in Japanese; complete biocompatibility/EMC/cybersecurity justifications; finalize risk management per JIS Q 14971; prepare software lifecycle documentation for SaMD (IEC 62304) and usability (JIS T 62366‑1); book RCB slot (Ninsho) or request PMDA pre‑submission consult (Shounin); align distributor PMS/GVP roles; draft recall/vigilance SOPs.
- Days 91–150
Submit Todokede/Ninsho/Shounin as applicable; support QMS conformity inspection (provide MDSAP report plus Japan addenda if leveraging it); execute labeling validations and UDI carrier placement; train Japanese affiliates on IFU and vigilance.
- Days 151–180
Address deficiency letters; finalize packaging artwork; rehearse import release, DHR/UDI capture, and complaint intake flows; set change‑control triggers (partial vs minor change) and KPI dashboards for PMS.
Questions
What are typical timelines for Ninsho and Shounin in Japan?
For Class II Designated Controlled devices, RCB Ninsho can take roughly 3–6 months from complete submission if testing and QMS evidence are in order. PMDA Shounin for Class II (non‑designated), III, and IV commonly ranges 9–18 months depending on novelty, clinical evidence, and iteration cycles. Class I Todokede is usually processed within days to a few weeks by the MAH/D‑MAH. QMS conformity inspection scheduling can add 1–3 months if MDSAP is not leveraged.
Do we need a Japanese legal representative or local MAH?
Yes. Only a Japan‑licensed MAH can hold Todokede/Ninsho/Shounin. Foreign manufacturers must either establish a Japanese MAH or appoint a Designated MAH (D‑MAH) to act as the legal marketing authorization holder. Additionally, foreign manufacturing sites must obtain foreign manufacturer registration under the PMD Act. The MAH/D‑MAH bears GVP responsibilities, labeling control, vigilance, and recall execution.
Is MDSAP accepted in lieu of Japan’s QMS inspection?
Japan participates in MDSAP, and PMDA/MHLW generally accept MDSAP audit reports to substitute or reduce QMS conformity inspections when scope and sites match. However, Japan‑specific requirements and product‑scope documentation still must be submitted, and authorities retain discretion to conduct focused or for‑cause inspections. MDSAP does not replace product technical review (Ninsho/Shounin).
Are FDA 510(k) or CE MDR approvals recognized in Japan?
Japan does not automatically recognize FDA or CE approvals. However, foreign approvals, clinical data, and test reports to international standards can support your technical justification. Using JIS‑adopted standards (e.g., JIS T 0601‑1) and providing complete Japanese documentation are still required. PMDA will assess benefit‑risk, labeling, and performance for Japan’s intended use and population.
What are common reasons for PMDA or RCB rejections or deficiency letters?
Frequent issues include misclassification or incorrect JMDN code, incomplete or untranslated technical sections, insufficient risk management per JIS Q 14971, gaps in software lifecycle or cybersecurity documentation, labeling/IFU claims not matching the intended use, missing JIS‑aligned test reports, inadequate biocompatibility or sterilization evidence, and weak GVP/PMS procedures at the MAH/D‑MAH.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
The Medical Device Production Guide
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- What the QMSR changed in February 2026
- Supplier to finished build
- Inspect, review, correct
- Labels, UDI and traceability
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