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

Process Package — Marketing Authorization Japan (PMDA)

Complete framework for Japanese PMDA medical device authorization. Covers DMAH designation, Foreign Manufacturer Registration (Form 63-5), JMDN code mapping, the three pathways (Todokede / Ninsho / Shonin), STED dossier, ICH E5 ethnic factor assessment, and tempu bunsho management.

What’s included:

• SOP-REG-JP Marketing Authorization Japan — full procedure: MAH/DMAH and KYOKA Types, Form 63-5 Foreign Manufacturer Registration, JMDN code system, three-pathway selection logic (Todokede for Class I, Ninsho via RCB for Class II/III with certification standards, Shonin via PMDA for the rest), STED in Japanese, MHLW Ordinance 169 J-QMS, tempu bunsho management with linkage to vigilance.
• F-REG-JP.1 JMDN Classification + Pathway Selection (Word) — structured worksheet for JMDN code mapping with rationale, 6-question pathway decision tree, ICH E5 ethnic factors assessment (critical for Shonin pathway devices), and approval by RA Manager + DMAH Regulatory Lead.

Why this package: Japan’s classification logic is unique — the JMDN code (not your judgment) determines the class and pathway. This package gives you the framework to identify the correct JMDN code and document the rationale for PMDA review. ICH E5 ethnic factor assessment is included for Shonin-pathway devices.

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