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CATÉGORIE: REGULATORY PATHWAYS

NHI (Assurance maladie nationale japonaise)

Le système d'assurance maladie universel japonais couvrant plus de 70% des dépenses en dispositifs médicaux.

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

  1. Separate regulatory approval from reimbursement/listing pathways.
  2. Prepare health-economic and clinical value dossiers for payers.
  3. Align coding, pricing applications, and post-listing evidence generation.
  4. 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

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TERMES CONNEXES

Shonin (Approbation pré-commercialisation Japon)Titulaire DMAL