MDL review targets
Class II 15-day screening target, Class III 75 days, Class IV 90 days — under the February 2026 Version 5 guidance.
Free field guide · PDF
Canada Health Canada Medical Device Licensing2026 Field Guide
MDL review targets, the MDEL establishment rule, and the 2026 fee schedule — under the February 2026 Version 5 guidance.
- Class II target
- 15 days
- MDEL standard
- 120 days
- Right to Sell / yr
- CAD $460
Sourced from Health Canada 2026 guidance and the MDL fee schedule.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — Health Canada 2026 guidance and the MDL fee schedule.
The MDEL rule
The 120-day MDEL service standard and the April 1 Annual Licence Review you must not miss.
The dossier reality
ISO 13485 expectations, bilingual labeling, and why deficiencies cost real money on Class III/IV files.
Sources & scope
- meddeviceguide.com, Canadian medical device licence changes (Version 5 guidance).
- qualitysmartsolutions.com, MDEL licence in Canada.
- mddionline.com, a primer on Canadian medical device regulations.
- canada.ca, management of applications for medical device licences.
This guide is market-access intelligence, not regulatory or legal advice. Health Canada timelines, fees, and classification rules are product-specific — professional review is required before business use.
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A Market Access Strategy Session maps your Health Canada route — classification, MDL/MDEL sequencing, and the bilingual labeling plan.
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