Japan medical device regulations
Official sources linkedPMDA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| PMDA | Pharmaceuticals and Medical Devices Agency - Official Portal PMDA homepage, not a legal instrument. Not ingested. | General | — | Official |
| PMD Act (Act No. 145 of 1960) | Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices Controlling Japanese text from e-Gov lawdata 335AC0000000145 (Showa 35 Act No. 145). The Ministry of Justice English translation is ingested as a separate unofficial-for-control expression. e-Gov public HTML is a JavaScript shell; ingest uses the XML API. | General | — | Official |
| PMD Act Amendments 2024 | Latest PMD Act Amendments and Updates PMDA regulatory-info collection, not a separate amending instrument. Current text is jp-pmd-act. | General | — | Official |
| Shonin Approval | Medical Device Regulations and Approval/Certification PMDA Shonin overview page, not the PMD Act. Not ingested. | Registration | — | Official |
| Ninsho Certification | Third-Party Certification (Ninsho) - RCB Assessments PMDA Ninsho/RCB overview page. Not ingested. | Registration | — | Official |
| Todokede Notification | Medical Device Standards for Class I Notification PMDA Class I standards portal. Not ingested. | Registration | — | Official |
| Device Classification | Medical Devices Regulatory Information Portal PMDA classification portal, not a classification ordinance. Not ingested. | Classification | — | Official |
| JMDN Generic Names List | Japanese Medical Device Nomenclature (JMDN) Catalogue Official PMDA JMDN list confirmed through July 2026: 4,496 generic-name rows with JMDN code, official Japanese name and definition, risk class when assigned, GHTF rule, and regulatory flags. Parsed by the PDF table coordinates so wrapped names remain separate from their definitions. | Classification | — | Official |
| MHLW Ordinance No. 169 | Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In-vitro Diagnostic Reagents Controlling Japanese QMS ordinance (Heisei 16 MHLW Ordinance No. 169), e-Gov lawdata 416M60000100169. The previous metadata URL was a PMDA portal, not the ordinance text. No government English translation was found on Japanese Law Translation for this ordinance. | GMP/QMS | — | Official |
| Foreign Manufacturer Accreditation | Accreditation of Foreign Manufacturers PMDA foreign-manufacturer portal. Not ingested. | Registration | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Continue from regulations into practical research
Keep Japan as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Classify a device for Japan
Check a preliminary PMDA risk class.
Search registered products
Inspect public PMDA records.
Compare products across markets
Search the same product in multiple country registries.
Build a registration plan
Estimate pathway, government fees, preparation, and review time.
Build a reusable product master
Structure company, product, model, approval, and evidence facts once.
Map dossier reuse and deltas
Compare existing evidence against Japan needs.
Build a market-launch workpaper
Connect route, evidence, labels, representatives, and launch dependencies.
Assess a regulatory change
Test a current PMDA update against one product and its evidence.