The AMMPS review
Complete dossiers get a decision within ~120 days — on the TARKHISS platform, with foreign approvals supporting but never replacing registration.
Free field guide · PDF
The AMMPS agency, the 120-day decision clock, and the ISO 13485 gate — with the dossier essentials and change rules.
Sourced from AMMPS guidance and verified 2026 publications.
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What's inside
Every figure in this guide traces to a named source — AMMPS guidance and verified 2026 publications.
Complete dossiers get a decision within ~120 days — on the TARKHISS platform, with foreign approvals supporting but never replacing registration.
Imported Class IIa/IIb/III devices need ISO 13485 or equivalent — plus French or Arabic labeling, FSC, and local agent authorization.
5-year validity, 6–12 month practical timelines for new products, and change-control rules across the product lifecycle.
This guide is market-access intelligence, not regulatory or legal advice. AMMPS timelines, fees, and review practice change — professional review is required before business use.
Market Access Strategy Session
A Market Access Strategy Session maps your AMMPS route — dossier sequencing, ISO 13485 readiness, and French/Arabic labeling.
Professional review is required before business use.
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