Post-Market
Obligations that apply after a device is legally approved for marketing and placed on the Japanese market. Post-market compliance in Japan is centred on the MAH, who bears primary statutory responsibility to MHLW for all surveillance, reporting, and recall activities throughout the device's market life.
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 |