Navigate Japan's medical device requirements, and take Japanese devices global.
Two journeys: foreign manufacturers seeking Japanese market access, and Japanese manufacturers seeking US, EU, UK and other approvals.
Key facts
Entering Japan
For foreign manufacturers: classification, pathway, MAH or DMAH coordination, STED dossier and QMS conformity.
Japan to global
For Japanese manufacturers: AI-assisted gap assessment of the existing dossier, expert delta review, remediation, submission support until certification, then post-market and complaint handling.
Pathways
- Class I: pre-market notification (todokede) to PMDA
- Class II, and some Class III devices with certification standards: third-party certification (ninsho) by a Registered Certification Body
- Other Class II, and Class III and IV: pre-market approval (shonin) by MHLW after PMDA review
- PMDA consultations before submission
What you will need
- Application in Japanese, in STED format
- Essential Principles conformity checklist
- Non-clinical test data, and clinical data where required
- Foreign manufacturer registration details
Sequence and decision points
- 01ClassifyIdentify the JMDN code and class.
- 02ConsultPMDA consultation on evidence and pathway, where useful.
- 03Appoint MAH or DMAHLocal licence holder responsible for the product.
- 04Register foreign sitesForeign manufacturer registration.
- 05SubmitNotification, certification or approval application in Japanese.
- 06QMS conformityAssessment of the QMS to Ordinance No. 169.
- 07Launch and monitorPost-marketing safety management under GVP.
QMS conformity with MHLW Ministerial Ordinance No. 169, aligned with ISO 13485:2016, confirmed through QMS conformity assessments.
A Marketing Authorization Holder (MAH) licensed in Japan is responsible for the product. Foreign manufacturers can appoint a Designated MAH (DMAH) to hold approvals.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
PMDA publishes review time targets for approval applications; certification and notification routes are shorter. Fees are set by MHLW and the certification body.
After market entry
- Post-marketing safety management under the GVP Ordinance
- Adverse event and malfunction reporting to PMDA, with timelines by seriousness
- Change applications and minor change notifications
- Periodic QMS conformity reassessment
How we help
- PMD Act classification and pathway strategy
- STED dossier preparation support
- QMS gap assessment against Ordinance No. 169
- Coordination with your MAH or DMAH
- Japan to global: AI-assisted gap assessment against MDR, IVDR and FDA requirements
- Expert delta review, remediation and submission support for the US and EU
- Post-market and complaint handling with IntelliVigilance AI
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about Japan
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Can a Japanese dossier be reused for the EU or US?
Much of the technical evidence can. Structure, clinical evidence expectations and post-market requirements differ, so we run a gap assessment of the existing dossier, an expert delta review and targeted remediation.
Does Ordinance No. 169 compliance help with ISO 13485 and MDSAP?
Yes. The ordinance was revised to align with ISO 13485:2016, and Japan participates in MDSAP.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.