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類別: REGULATORY PATHWAYS
NHI（日本國民健康保險）
日本覆蓋超過70%醫療器材支出的全民健康保險制度。在PMDA承認批准後獲得NHI醫保報銷目錄是在日本商業可行性的關鍵。
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（日本國民健康保險） across 27 authorities in real time.
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