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Application Dossier Structure

STED alignment in Japan​

Japan's Shonin application dossier structure broadly follows the IMDRF STED (Summary Technical Documentation) framework, reflecting Japan's membership in IMDRF and MHLW's efforts to harmonise with international best practice. However, Japan-specific sections (particularly the Essential Principles checklist and JMDN classification documentation) are added.

Overview of modules​

ModuleContent
1 — AdministrativeApplication form, fees, MAH licence, FMR certificate
2 — SummarySTED overview, Japanese-language safety/efficacy summary, benefit-risk
3 — Device descriptionDevice description, intended use, JMDN justification, specifications, accessories
4 — Non-clinical studiesBiocompatibility, sterilisation, electrical safety, EMC, software, mechanical testing
5 — Clinical evidenceClinical evaluation report, clinical study summaries, literature review
6 — ManufacturingManufacturing process description, QMS compliance, FMR site details
7 — LabellingDraft Japanese label and IFU
8 — Essential PrinciplesCompleted Essential Principles checklist with standard references

Electronic submission requirements​

PMDA requires electronic submission via the PMDA electronic gateway (EDRP). Requirements include:

  • Specific file naming conventions (published by PMDA)
  • Document format: primarily PDF for narrative content; XML for structured data
  • Electronic signatures where required
  • Each module submitted as a separate package

PMDA provides an applicant guidance document for electronic submission format requirements. Confirm the current version before finalising your submission package — requirements have been updated over time.

Common deficiency types​

The most common reasons for PMDA returning or questioning applications:

  1. Incomplete or inadequate Japanese-language summaries
  2. Essential Principles checklist with gaps or unsupported claims
  3. Clinical evidence that does not address the Japanese patient population
  4. Manufacturing module that does not clearly identify all manufacturing sites
  5. Labelling that does not include all mandatory PMD Act label elements
  6. FMR number not yet issued at time of submission