PMDA · structured requirements

🇯🇵 Japan medical device regulatory data

Explore the medical device requirements currently available for Japan, organized by topic and linked to official sources.

4 facts3 dimensions2 official sourceslatest verification 2026-08-13

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

authorization.duration

Type: Route Dependent
Description: Product approval/certification is not generally a simple five-year renewal; foreign manufacturer registration and QMS conformity have separate 5-year maintenance cycles.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

change.available-outcomes

Outcomes: Notification Or Administrative Update
Prior Approval Amendment Or Variation
New Registration Or New Application
Description: Use PMDA pre-consultation to classify ambiguous changes.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

change.new-application-triggers

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

market-entry.representative-change

Path Code: MAH Transfer Or New Approval Route Requires Product Specific Review
Fresh Registration: Route Dependent
Minimum Handover: approval/certification files
QMS and GVP records
complaints/adverse events/recalls
manufacturer registrations
Japanese labels
distribution and inventory records
Notes: Changing a filing intermediary is not the same as transferring the MAH/DMAH.