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Iran FDA · structured requirements

🇮🇷 Iran medical device regulatory data

Explore the medical device requirements currently available for Iran, organized by topic and linked to official sources.

2 facts2 dimensions2 official sourceslatest verification 2026-08-13

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Market-access route or official registration surface

registration.market-access-route
Official document
SubmissionSurface

IMED portal; detailed current public guidance could not be reliably extracted

VerifiedHighlights
  • The national medical-device operational surface is the IMED portal.
Caveat

Current forms, public guidance and dimension-level rules remain unverified; WHO 2022 is retained only as the authority-discovery baseline.

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