The three routes
Todokede for Class I, Ninsho certification for Class II, Shonin approval for Class III/IV — chosen by JMDN code.
Free field guide · PDF
Japan PMDA Medical Device Registration2026 Field Guide
The Todokede, Ninsho, and Shonin routes, the mandatory MAH, and QMS conformance — for one of the world's most demanding markets.
- By JMDN code
- 3 routes
- Shonin timeline
- ~12 mo
- QMS certificate
- 5 yrs
Sourced from PMDA regulatory process guidance and industry filings.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — PMDA regulatory process guidance and industry filings.
MAH, QMS, consultations
Mandatory MAH ownership, 5-year QMS conformance certificates, PMDA consultation meetings, and Japanese labeling.
Expedited pathways
Generic-device equivalence, the Conditional Early Approval System, and Sakigake designation for breakthrough devices.
Sources & scope
- Japan PMDA regulatory approval process guidance (technical deck).
- BioCardia press release, Shonin submission timing — September 2026.
- MedicalDeviceRegistration.com, Japan PMDA approval process.
- Emergo, major changes to the Japanese registration process.
This guide is market-access intelligence, not regulatory or legal advice. PMDA pathways and MAH requirements are product-specific — professional review is required before business use.
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A Market Access Strategy Session maps your PMDA route — registration, MAH, and QMS sequencing.
Professional review is required before business use.
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