PMDA Registration SOP + JMDN Template — Shonin / Ninsho / Todokede (Japan)

Process Package — Vigilance Reporting Japan (PMDA)

Complete framework for Japanese medical device vigilance under PMD Act Art. 68-10. Covers the LISTED vs UNLISTED logic (events already in tempu bunsho follow 30-day path; UNLISTED follow stricter 15-day path), causality assessment, mandatory PSB/PSD fax notification for deaths, and tempu bunsho management strategy.

What’s included:

• SOP-VIG-JP Vigilance Reporting Japan — full procedure: 4-question reportability assessment, the LISTED vs UNLISTED logic that drives 15-day vs 30-day timelines, mandatory PSB/PSD fax notification within 7 days for deaths, tempu bunsho update strategy, MHLW Ordinance 135 GVP, foreign event tracking.
• F-VIG-JP.1 Japanese Reportability Decision Worksheet (Word) — structured assessment with tempu bunsho version verification, specific adverse-event listing check, LISTED/UNLISTED classification, timeline calculator (15 vs 30 days), tempu bunsho update trigger flag, and PSB/PSD fax callout for deaths.

Why this package: The LISTED vs UNLISTED logic is unique to Japan and frequently misapplied. This template forces the correct check, documents the rationale, and identifies opportunities for proactive tempu bunsho update — buying you more time on future events.

Format: Microsoft Word
Updated: May 2026
Delivery: Instant download after purchase