Before Reordering a Medical Device SKU, What Public Records Should You Check?

If your team imports, distributes, procures, or onboards medical devices in the United States or Canada, you are typically the responsible party for confirming the device is appropriately authorized at the time of import or sale. Before a purchase order, before a reorder, or as part of a periodic supplier review, your team often needs a dated, source-backed snapshot of what FDA and Health Canada have publicly published about that one device — licences, registration, recalls, safety alerts, and any visible red flags.

This article walks through what such a public-record check covers, which official databases your team would consult, and what a useful, dated snapshot looks like in practice.

When this kind of check matters

The pre-transactional public-record check is most useful at predictable moments:

• Before placing a purchase order on a new device line.
• Before reordering a SKU after time has passed or after a recall window.
• During product onboarding for a new distributor or new manufacturer.
• During periodic supplier review of devices you already carry.
• When a customer or your own RA / QA reviewer asks for the regulatory evidence behind a specific device.
• Before signing a distribution, sourcing, or supplier agreement.
• Before issuing a Letter of Intent in a medical-device commercial deal.

The check is not a substitute for your qualified RA / QA / legal / regulatory professional's review. It is the public-source evidence layer that lets that review run faster and on better-cited material.

Public records you can review before buying or reordering

Both FDA and Health Canada publish primary databases that anyone can search. The boundary you care about is what each database does and does not tell you.

United States — what FDA publishes

• Establishment Registration & Listing — confirms a manufacturer or initial importer has registered with FDA and listed the device. Registration / listing is not approval, clearance, or authorization — see FDA's Important Reminders About Registration and Listing. The searchable surface is the Establishment Registration & Device Listing.
• 510(k) Premarket Notification — substantial-equivalence clearance. 510(k) clearance is not "FDA approval"; "approved" is reserved for PMA. Search the 510(k) database.
• De Novo classification — for novel low-to-moderate risk devices. See the De Novo Classification Database.
• Premarket Approval (PMA) — Class III approval. Search the PMA database.
• CDRH Recalls and Enforcement Reports — historical and current corrections, recalls, and removals. The CDRH Recall Database is the canonical surface; openFDA's device/enforcement endpoint is the JSON view.
• MAUDE — Manufacturer and User Facility Device Experience adverse-event reports. Public vigilance / incident-reporting surfaces have known limitations and may not capture every device problem, supplier communication, or reportable event; absence of a public record does not mean absence of risk.
• Warning Letters and Import Alerts / Refusals — useful as a check on the manufacturer or its facility. See FDA's Warning Letters, Import Alerts, and Import Refusals.
• Safety Communications — FDA's public communications about specific device-class safety issues.

Canada — what Health Canada publishes

• MDALL (Medical Devices Active Licence Listing) — Class II / III / IV active medical-device licences. Per Health Canada, MDALL helps purchasers verify that the manufacturer of a Class II / III / IV medical device holds an active medical device licence.
• MDEL (Medical Device Establishment Licence) — required for Canadian importers and distributors of medical devices, and for manufacturers of Class I devices. MDEL is establishment-level and does not, by itself, prove that a specific product is licensed — that is what MDALL surfaces. See Health Canada's MDEL guidance.
• Recalls and Safety Alerts — Health Canada's public feed of recalls, advisories, and safety communications. See recalls-rappels.canada.ca.
• Medical Device Vigilance / Incident Reports — Health Canada's vigilance surface. Public vigilance / incident-reporting surfaces have known limitations and may not capture every device problem, supplier communication, or reportable event; absence of a public record does not mean absence of risk.

What a "dated public-source check" actually looks like

A useful pre-PO record reads like a structured snapshot, not a marketing summary. It typically contains:

• A cover with the report ID, jurisdiction (US or Canada), product name, manufacturer, and searched-on date.
• A per-source as-of date for each database — when the analyst opened MDALL, MDEL, FDA Establishment Registration & Listing, the recall feed, and so on.
• A source-results table listing what was found in each database, with the source URL and the search keys used so the buyer's RA / QA reviewer can replicate the search.
• A "missing or uncertain" section that names the gaps — what was searched but not found, where Health Canada's open-data design limits per-record permalinks, where FDA's per-event surfaces under-report.
• A copy-paste list of follow-up questions the buyer can send to the supplier or manufacturer.
• Verbatim limitation language (see "What this is not", below).

Each TrueMedDevice Public Regulatory Status Snapshot follows that structure. Two illustrative format previews — one for Canada, one for the United States — are available online.

How TrueMedDevice fits in

Our $199 Public Regulatory Status Snapshot is a single dated PDF, prepared by an analyst (not auto-generated), scoped to one product, one company, one country (United States or Canada), one dated report. We do the public-database lookups your team would otherwise do by hand, organize them into a source-backed report, and deliver it within two business days. Reviewing the same device in both countries means two separate reports, with the boundary against mixing jurisdictions kept explicit.

The snapshot is a research-and-review aid for your qualified professional. It is not a regulatory determination. It does not replace your RA / QA, regulatory, legal, supplier-quality, or procurement reviewer.

What this kind of check is not

• Not legal advice, not a regulatory determination, not an import authorization, and not a purchasing recommendation.
• Not a final marketability determination. A Health Canada licence or an FDA clearance is not the same as a fitness-for-your-transaction conclusion — that conclusion belongs to your qualified professional.
• Not a safety guarantee. Public recall and advisory pages may not reflect supplier or manufacturer communications in real time. Public vigilance / incident-reporting surfaces have known limitations and may not capture every device problem, supplier communication, or reportable event.
• Not a compliance certificate. The phrase "compliance certificate" is intentionally absent from any TrueMedDevice public-record snapshot.
• Not a substitute for your team's qualified review. Final decisions on importing, distributing, purchasing, or onboarding remain with your RA / QA, regulatory, legal, supplier-quality, or procurement professional. The snapshot's job is to organize the public record cleanly so that review runs faster.

Start a check or request the illustrative sample

FAQ

Does Health Canada or FDA require a TrueMedDevice report before importing or selling a medical device?

No. A TrueMedDevice Public Regulatory Status Snapshot is research and review support based on the public regulatory record — it is not required by any regulator. It is a dated public-source record that supports your qualified RA / QA, regulatory, legal, supplier-quality, or procurement professional's own review.

Is the public-record check a compliance certificate?

No. The phrase "compliance certificate" is intentionally absent from any TrueMedDevice snapshot. The snapshot is a public-data check, not a certification, not a regulatory determination, and not a purchasing recommendation.

How is FDA "clearance" different from FDA "approval"?

FDA "clearance" is reserved for the 510(k) substantial-equivalence pathway. FDA "approval" is reserved for the Premarket Approval (PMA) pathway used for higher-risk Class III devices. FDA registration and listing are separate again and confirm only that an establishment has registered and a device has been listed — not that the device has been approved, cleared, or authorized. The snapshot uses each term only when directly citing an official FDA record, with the official identifier and source URL.

What is the difference between MDALL and MDEL in Canada?

MDALL (Medical Devices Active Licence Listing) is the licence-level surface for Class II / III / IV medical devices — it confirms that the manufacturer of a specific device holds an active medical device licence. MDEL (Medical Device Establishment Licence) is establishment-level — it confirms that an importer, distributor, or Class I manufacturer holds an active establishment licence. MDEL by itself does not prove that a specific product is licensed; that is what MDALL surfaces.

What if no public record is found for a specific device?

"No public record found" means no record surfaced in the named databases under the search keys used on the searched-on date. It does not mean no record exists, no event occurred, or no risk is present. Public databases lag actual events; vigilance surfaces have limitations. The snapshot's "missing or uncertain" section names the gaps, and the supplier follow-up questions list is the buyer's tool for closing them with the manufacturer.

Why is the illustrative sample delivered by email rather than as a public download?

So we know who is reviewing it and can route follow-up correctly. The lead-capture form on the sample page collects your name, work email, company, role, company type, the product category you care about, and the country of interest. Submitting the form is how recipients receive the sample. There is no anonymous public download.