Pre-Market
Everything required to place a medical device on the Japanese market — from determining the correct classification and regulatory pathway through to preparing the application dossier and obtaining approval, certification, or completing notification.
In this section
| Sub-section | What it covers |
|---|---|
| Classification | JMDN codes, Classes I–IV, IVD, SaMD, borderline products |
| Approval (Shonin) | Full PMDA/MHLW approval process for Class III and IV devices |
| Certification (Ninsho) | RCB certification pathway for Class II and eligible Class III devices |
| Notification (Todokede) | Prefectural notification for Class I devices |
| Clinical Evidence | Clinical trials, foreign data, clinical evaluation reports, IVD performance evaluation |
| Technical Documentation | Dossier structure, device description, risk management, software, Essential Principles |
Key decision points
Step 1 — Classify your device. Look up the JMDN code and confirm the risk class. This determines everything that follows.
Step 2 — Choose the pathway. Class I → Todokede. Class II with recognised standard → Ninsho. Class II without standard or Class III/IV → Shonin.
Step 3 — Secure an MAH. You cannot file an application without a Japan-domiciled MAH in place.
Step 4 — Complete FMR. Foreign manufacturing sites must be registered before or simultaneously with the pre-market application.
Step 5 — Engage PMDA early (Shonin only). For novel, high-risk, or technically complex devices, book a PMDA pre-submission consultation before finalising your dossier strategy.