Japan medical device registration timeline
Source-linked clocksPharmaceuticals and Medical Devices Agency (PMDA) review clocks and end-to-end planning ranges, using the 4-class (I, II, III, IV) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I (一般医療機器)(Pre-marketing notification (製造販売届, Todokede) to PMDA) PMDA states plainly that it does not review the notification (提出された届書については審査を行いません) — it is filed on the notifier’s own responsibility, so there is no decision period to wait out | 0 days | 0 days | — | Verified |
| Third-party certification (認証)(Registered certification body (登録認証機関) under Art. 23-2-23) Zero is recorded because the government sets no clock here, not because certification is instant: Enforcement Regulation Art. 129(3)(i) makes each registered certification body state its own standard processing period in the business rules it files for MHLW approval, so the period is per-body and there is no national figure to publish | 0 days | 5-6 months | — | Verified |
| New medical device application (新医療機器)(PMDA approval review (Shonin)) PMDA publishes this target by application type, not by risk class; priority-review new devices have a 9-month target | 12 months | 7.1-12 months | — | Verified |
| Improved device — clinical data (改良医療機器（臨床あり）)(PMDA approval review (Shonin)) PMDA publishes this target by application type, not by risk class | 9 months | 6.5-8.8 months | — | Verified |
| Improved device — no clinical data (改良医療機器（臨床なし）)(PMDA approval review (Shonin)) PMDA publishes this target by application type, not by risk class | 6 months | 4.9-7.3 months | — | Verified |
| Follower medical device application (後発医療機器)(PMDA approval review (Shonin)) PMDA publishes this target by application type, not by risk class | 4 months | 2-6 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Japan Medical Device Registration Process
Step-by-step PMDA registration process. Total estimated timeline: 0 days.
Step 1: Device Classification
2-4 weeksClassify device under PMDA rules: Class I (Todokede), II-III (Ninsho), III-IV (Shonin).
Step 2: Appoint MAH/DMAH
4-8 weeksForeign manufacturers must appoint a Marketing Authorization Holder (MAH) in Japan.
Step 3: Foreign Manufacturer Accreditation
1-2 monthsRegister foreign manufacturing site with PMDA. Required before product registration.
Step 4: QMS Compliance
2-4 monthsPMDA conducts QMS/GMP audit of manufacturing site. MDSAP accepted as alternative.
Step 5: Pre-Submission Consultation
1-3 monthsRecommended for Class III/IV devices. Discuss clinical data and testing requirements.
Step 6: Shonin/Ninsho Application
1-2 weeksSubmit application to PMDA (Shonin) or Registered Certification Body (Ninsho).
Step 7: PMDA Review
10-14 monthsTechnical review by PMDA. Average 10-14 months for Shonin (Class III-IV).
Step 8: Approval
2-4 weeksMHLW issues approval. Device can be marketed in Japan through the MAH.
Pioneer designation for devices developed in Japan first, carrying prioritised consultation and a dedicated PMDA concierge
Eligibility: Ground-breaking technology, Severe disease with high unmet need, Early development in Japan
Expedited review for serious conditions
Eligibility: Serious condition, Limited treatment options
- Marketing Authorization Holder (MAH) in Japan
- Foreign Manufacturer Registration (FMR)
- QMS certification (MHLW Ordinance 169)
- Japanese labeling and IFU
- JMDN classification
- Route is decided by the JMDN general name, not by the applicant: Class I notifies, a Class II or designated Class III name with a certification standard is certified by a registered body, and everything else is approved by MHLW on a PMDA review
- The application category (new / improved with clinical / improved without clinical / follower) is what sets both the review clock and the fee, so the same physical device can sit on very different timelines depending on how much of it is novel
MDSAP: Single audit satisfies PMDA QMS requirements
Reviewed 2026-08-30. End-to-end totals remain planning estimates.