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Lifecycle of a Medical Device in Japan

A medical device's regulatory life in Japan spans three broad phases: pre-market, approval/certification, and post-market. Each phase has defined obligations for the MAH and manufacturer.

Phase 1 — Pre-market​

Classify the device. Every device must be assigned a JMDN code and a risk class (I–IV). The class determines the regulatory pathway. See How Classification Works.

Determine the pathway. Based on class and whether an applicable recognised standard exists:

  • Class I → Todokede (notification)
  • Class II (with recognised standard) → Ninsho (certification via RCB)
  • Class II (no standard) or Class III/IV → Shonin (approval via PMDA/MHLW)

Secure an MAH. The Japan-domiciled MAH must be in place before a formal application can be filed.

Complete Foreign Manufacturer Registration (FMR). Filed by the MAH simultaneously with or before the pre-market application.

Prepare the dossier. Compile technical documentation, clinical evidence, risk management, and manufacturing quality information in the format required for the chosen pathway.

PMDA pre-submission consultation (for Shonin). For novel or complex devices, early PMDA consultation is strongly recommended to align on data requirements and avoid surprises during review.

Phase 2 — Approval / Certification / Notification​

Shonin (Approval — Class III/IV). Application submitted to PMDA → scientific review (typically 12–18+ months for standard review) → PMDA review report → MHLW approval decision → Shonin number issued to MAH.

Ninsho (Certification — Class II/some III). Application submitted to chosen RCB → RCB review (typically 3–9 months) → Ninsho certificate issued to MAH by RCB.

Todokede (Notification — Class I). Notification filed with prefectural government → acknowledged → MAH may begin marketing.

Phase 3 — Post-market​

Re-examination period. For Shonin devices, a re-examination surveillance period begins at approval (typically 3–7 years depending on device type). The MAH must collect use-results data and submit a re-examination application at the end of the period.

GPSP surveillance. MAH operates a post-market surveillance programme compliant with the Good Post-market Study Practice (GPSP) Ordinance. This includes use-results surveys, complaint collection, and periodic safety reporting.

Adverse event reporting. The MAH must report serious adverse events to MHLW within 15 or 30 days depending on event type.

Approval maintenance. Significant device changes require Partial Change Approval (Ichibu Henko) — a new application to MHLW. Minor changes require notification only.

Re-evaluation. MHLW may at any time initiate a re-evaluation of any approved device class if new safety concerns arise. This is distinct from the MAH-initiated re-examination.

End of market life. The MAH files a withdrawal notification with MHLW. Post-withdrawal obligations (records, complaint handling for devices already in use) continue for defined periods.