Post-Market
Obligations that apply after a device is on the Japanese market. Post-market compliance in Japan centres on the MAH, who bears primary responsibility for all surveillance, reporting, and recall activities.
In this section
| Sub-section | What it covers |
|---|---|
| Adverse Event Reporting | What to report, MAH obligations, 15/30-day timelines, near-miss reporting |
| Recalls and Field Safety | Mandatory and voluntary recalls, MHLW notification, FSCAs and FSNs |
| Post-Market Surveillance | GPSP framework, re-examination, periodic reporting, post-market clinical follow-up |
| Labelling and IFU | Japanese labelling requirements, dual-language rules, eIFU, advertising |
| Approval Maintenance and Changes | Ichibu Henko, minor change notifications, approval transfer and withdrawal |