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类别: REGULATORY PATHWAYS
NHI（日本国民健康保险）
日本覆盖超过70%医疗器械支出的全民健康保险制度。在PMDA承认批准后获得NHI医保报销目录是在日本商业可行性的关键。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
NHI commonly refers to National Health Insurance systems (e.g., Taiwan NHI, Japan’s NHI reimbursement context) that determine payment and listing after (or parallel to) regulatory approval—critical for commercial access, not a substitute for device registration.
PROCESS / STEPS
- Separate regulatory approval from reimbursement/listing pathways.
- Prepare health-economic and clinical value dossiers for payers.
- Align coding, pricing applications, and post-listing evidence generation.
- Monitor policy changes that affect device categories and fees.
EXAMPLES
- In Japan, PMDA/MHLW approval and NHI reimbursement listing are sequential commercial gates for many devices.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to NHI（日本国民健康保险） across 27 authorities in real time.
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