← 所有術語
類別: REGULATORY PATHWAYS

承認(日本上市前批准)

PMDA/厚生勞動省對日本II類（無標準）、III類和IV類醫療器材的上市前批准途徑。承認包括PMDA科學審評和厚勞省正式批准。

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

Shonin is Japan’s PMDA/MHLW pre-market approval path for higher-risk devices (typically Class III/IV and some Class II without standards).

PROCESS / STEPS

  1. Confirm Japanese classification and pathway (Shonin vs Ninsho vs Todokede).
  2. Engage a DMAL holder.
  3. Prepare dossier and consult PMDA as needed.
  4. Complete review and MHLW authorization; plan PMS.

EXAMPLES

  • A novel implant without a certification standard typically requires Shonin rather than Ninsho.

RELATED GUIDES & TOOLS

SOURCES

Track regulatory signals related to 承認(日本上市前批准) across 27 authorities in real time.

START FREE →

相關術語

認證(日本第三方認證)