FDA & Health Canada · Licences · Recalls · Standards · Enforcement
MedTech Signal brings FDA and Health Canada device authorizations, recalls, recognized standards, QMSR enforcement and AI/SaMD study evidence into one reviewable workspace — refreshed on a daily and weekly schedule, based on available public regulatory data, with every field linked back to the regulator record it came from.
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Licence databases, recall notices, recognized standards lists and enforcement records sit in separate portals, each with its own identifiers, states and update cadence. Teams rebuild the same spreadsheet every quarter, and a stale row can send a submission or a distribution decision the wrong way.
MedTech Signal keeps those records normalized, compared against the previous snapshot and attached to the watchlists your team actually monitors — without inventing conclusions the records don't support.
Platform
Company-level FDA to Health Canada candidate matching with scored evidence, and device-level candidates on the FDA records evaluated so far. Absence of a match is shown as No apparent Canadian match — never as an assertion that a device is unlicensed. Your review decisions persist.
Health Canada MDALL licences, devices and identifiers with active and archived states preserved, Health Canada recall records matched by identifier, catalogue number and normalized company name as Confirmed, Probable, Possible or No apparent match, plus watchlists and an alert feed.
FDA and Health Canada standards recognition side by side, with a change timeline covering new recognitions, withdrawals, edition, status and limitation changes. Health Canada's recognition page is currently unavailable at the source, so its recognitions may be behind FDA's.
FDA inspection citations, published observations and warning letters, kept distinct across Pre-QMSR and QMSR-era inspections and mapped to a controlled finding taxonomy. FDA publishes only part of its inspection record, so counts reflect what FDA has published, not all inspections.
Compare devices from the FDA AI-enabled device list on study design, cohort size, external validation and performance metrics. Values are machine-extracted from FDA decision summaries, review recommended, and each one shows its document, page and excerpt. Fields absent from the documents read Not found in public documentation.
Watch the devices, licences and companies your team owns, and each scheduled refresh reports what moved in an alert feed with Info, Attention and Critical severity, unread tracking, configurable email digests and push notifications for critical recall matches on paid plans.
How it works
Eight regulator sources are scheduled — licences and recalls daily, authorizations, standards and enforcement weekly. Each source shows its own last successful refresh, so a failing or partial source is visible rather than hidden.
Each refresh compares against the last good snapshot. Deterministic rules — no model inference — produce licence, identifier, recall, standards and impact events with Info, Attention or Critical severity.
Watch devices, licences and companies, and see matching changes in the alert feed with unread tracking. Email delivery is configurable per category (immediate, daily digest, weekly digest or off) and queues each event once; outbound email starts once a verified sender domain is connected.
Device and record pages show the source records side by side and link back to the originating regulator page, so a reviewer can verify a field in one click.
Built for review
A value stated in a published document, shown with its page number and excerpt.
Absent evidence is reported as absent, never counted as a negative finding.
Extracted values stay visibly unconfirmed until a person reviews them, and keep their original wording.
Where no Health Canada record can be matched, that is all we say — never that a device is unlicensed.
Coverage is limited to what each regulator publishes, and each screen shows the last successful refresh behind it.
Health Canada and the U.S. Food and Drug Administration today: MDALL licences and device identifiers, Health Canada recalls and recognized standards, FDA 510(k)/De Novo/PMA authorizations, FDA recognized consensus standards, FDA inspection and warning-letter enforcement data, and the FDA AI-enabled device list. Coverage is limited to what each regulator publishes.
No. Sources refresh on a schedule — licences and recalls daily, authorizations, standards and enforcement weekly — and each screen shows the last successful refresh for the source behind it. Where a source has not refreshed successfully, the workspace says so rather than presenting the data as current.
Only published regulator records, retrieved from official sources. MedTech Signal normalizes and organizes them, based on available public regulatory data, and links each screen back to the original record.
No. Cross-border relationships are candidates for your review, labelled No apparent Canadian match, Possible match, Probable or Matched. MedTech Signal never asserts that a device is not licensed.
Study designs, cohort sizes and performance metrics are machine-extracted from FDA decision summaries — review recommended — and shown with their document, page and excerpt. Extraction covers a growing subset of the FDA AI-enabled device list, and values absent from the documents read Not found in public documentation.
No. MedTech Signal summarizes published regulator records for information only. Confirm anything you rely on against the linked regulator record.
Sign up, add the devices, licences and companies you already track, and each scheduled refresh reports what changed in your alert feed. Plans from $299 per month per workspace — see pricing for what each tier covers.