Regulatory readiness for medical devices in Japan

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. 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.

Japan classifies devices I–IV by risk. Class I (General) typically requires only notification (Todokede). 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.

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. 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.

MHLW Ordinance No. 169 harmonizes with ISO 13485 but adds Japan‑specific elements. 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.

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. 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.

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. 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.

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.