Forms and PMDA Submission Portals
PMDA operates Japan's primary electronic submission gateway (EDRP) for Shonin applications and related submissions. Most formal pre-market applications and post-market regulatory submissions are processed through this system. Understanding the portal and form requirements is essential for efficient regulatory submissions.
PMDA electronic submission gateway (EDRP)
The Electronic Document Review and Processing system (EDRP) is PMDA's electronic submission gateway for:
- Shonin (approval) applications
- Ichibu Henko (partial change approval) applications
- Post-market study protocols (GPSP)
- Re-examination applications
EDRP account setup: MAHs must register for an EDRP account before submitting. PMDA provides guidance on account registration on its website. Account setup should be completed well before the planned submission date.
Submission format requirements: PMDA publishes detailed technical specifications for EDRP submissions — file formats, naming conventions, directory structure, and module organisation. These specifications are updated periodically. Always use the current version.
PMDA EDRP portal: pmda.go.jp — electronic submissions (registration and guidance available)
Key forms by application type
| Application type | Form source |
|---|---|
| Shonin application form | PMDA prescribed format; available on PMDA website |
| Ichibu Henko (partial change) | PMDA prescribed format |
| Todokede (Class I notification) | Prefectural government form (varies by prefecture) |
| FMR application | MHLW prescribed format; filed by MAH |
| MAH licence application | Prefectural government or MHLW form depending on device class |
| Adverse event report | MHLW prescribed format; submitted through PMDA system |
| GPSP survey protocol | PMDA prescribed format |
| Re-examination application | PMDA prescribed format |
PMDA pre-submission consultation booking
Pre-submission consultations with PMDA are booked through PMDA's consultation management system. The process:
- Access PMDA's consultation booking page (pmda.go.jp — consultation services section)
- Select the consultation type (RS Strategy Consultation, pre-application consultation, etc.)
- Submit a consultation request form with a brief description of the device and regulatory question
- PMDA confirms availability and assigns a consultation date (typically several weeks to months in advance, depending on consultation type)
- Prepare and submit the consultation briefing document by the PMDA-specified deadline before the meeting
Fee payment
PMDA charges fees for pre-submission consultations, application reviews, and QMS inspections. Fees are set by Cabinet Order and are published on PMDA's fee schedule. Fee payment is typically required at the time of application submission. The MAH is responsible for fee payment.
PMDA fee schedule: pmda.go.jp — fees