Guidance Documents
An index of PMDA and MHLW guidance documents, recognised standards, submission forms, and official portals for Japan medical device regulation.
PMDA and MHLW produce a large volume of guidance. This section organises the most relevant guidance by topic, device class, and type to help you find what applies to your situation quickly.
In this section
| Page | What it covers |
|---|---|
| All PMDA Guidance by Topic | Pre-market, post-market, QMS, clinical, digital health guidance |
| MHLW Notifications Index | Key administrative guidance by category |
| Guidance by Device Class | Guidance organised by Class I–IV and IVD/SaMD |
| Recognised Standards List | MHLW-designated standards for Ninsho certification |
| IMDRF Adoption Status | Which IMDRF guidance Japan has adopted |
| Forms and PMDA Submission Portals | Application forms, PMDA gateway, consultation booking |