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Regulatory and market intelligence

Reports built from public Health Canada, FDA and EU data with our in-house tools, delivered before or alongside a regulatory engagement. Each one cites its sources and the date the data was pulled, and says what the data cannot show.

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Built from public sources

  • Health Canada MDALL
  • MDEL listing
  • openFDA
  • FDA 510(k)
  • EUDAMED
  • ClinicalTrials.gov

Report types

  • Canadian market-entry scan

    Whether a comparable device is already licensed in Canada (MDALL, Class II to IV), who holds the licence, which MDEL holders operate in the category, and how crowded it is.

    Canadian market entry

  • US-to-Canada gap analysis

    FDA-cleared devices in a category with no active Canadian licence. Useful for manufacturers weighing Canada and for distributors looking at a category.

    How the comparison works

  • Importer and distributor landscape

    Licensed medical device establishments by activity and device class, from Health Canada’s public listing.

    Support for international manufacturers

  • Pathway fit check

    Likely classification and route in Canada, the US and the EU, plus CE mark and EUDAMED presence where public.

    The CUE Review

  • Competitor and predicate landscape

    FDA 510(k) clearances, ClinicalTrials.gov registrations and patent activity around your device.

    FDA support

  • Regulatory change briefs

    What changed, when, who is affected and what to do. Shorter briefs also appear in Insights.

    Read Insights

Coverage limits, stated up front

Public databases have gaps. Every report names them, so you know how far to rely on each result.

  • MDALL lists active licences for Class II to IV devices. Class I devices do not need a licence and do not appear.
  • Health Canada’s establishment licence listing has no public API, so MDEL holders are checked by manual search.
  • FDA 510(k), PMA and De Novo data sit in separate databases. Many devices are exempt from 510(k).
  • EUDAMED is still being rolled out. Missing entries do not mean a device has no CE mark.

What the reports are not

  • Not a promise of leads, sales, approvals or timelines. They describe what public data shows on the date it was pulled.
  • Not legal advice. Intelligence informs a regulatory strategy; it does not replace one.
  • Not a contact list. Reports do not include personal contact details. Any request involving personal data is checked against CASL and PIPEDA first.
  • Not a subscription or software product. The tools are in-house and used by us to prepare each report.

Where a report leads

Tell us about your device and the market you are aiming for.

A first conversation covers the device, its likely classification, where you are today and the date you are working to. Every enquiry goes through Crossbridge Partners, so there is one point of contact.

Discuss your regulatory pathway