A device company's deck usually carries its regulatory story in one line: "CE-marked, FDA 510(k) expected next year, launching in Asia." Each part of that line is public record or soon will be. Diligence on an early-stage company rarely checks it, because it means reading a dozen registries in a dozen formats. Here are the six checks that matter most, and what each one tells you.
1. Approved where, exactly, and since when
"CE-marked" and "FDA-cleared" are claims about specific products, under specific numbers, on specific dates. Find the registrations themselves. Check that the product in the deck is the product on the record, that the dates match the story, and whether anything has lapsed. A lapsed registration is a fact about the company's past management, and the deck rarely mentions it.
A clearance in one market does not register the device in any other. "FDA-cleared, so Asia is next" still means a separate registration in every Asian market.
2. Who holds the license in each market
In many markets the registration is held by a local entity, not the manufacturer. If that entity is the company's own subsidiary, the access belongs to the company. If it is an independent distributor, the access belongs to the distributor: end the relationship and the product cannot be sold there until it is registered again under someone else. For an early-stage company with its first one or two foreign markets, this is often the single largest hidden dependency.
3. What it was cleared against
A US 510(k) rests on a predicate device. Look at the predicate chain: which device the company claimed equivalence to, and which other companies cleared devices against the same predicates. Those are its closest competitors in the regulator's eyes, whether or not they appear on the competition slide.
4. Whether the device is classed the same way everywhere
Risk class decides the route, the evidence needed and the time. The same device can sit in different classes in different markets, and software especially is treated very differently from one market to the next: a medical device in one, exempt in another. If the plan assumes the home-market class everywhere, check how comparable devices were classed in the markets it names.
5. Whether the order of markets makes sense
Some markets shorten their review for devices already approved by a reference regulator; others give no credit. A plan that enters a credit-giving market before its reference approval exists, or that ignores a route the company already qualifies for, is costing time or money. Ask why this order.
6. Who is already registered there
For each target market, look at who already holds registrations in the same device area, and who sells for them. A crowded market changes the revenue case; an empty one is either an opening or a sign that the route is hard. Either way, the answer is on the record.
Run these checks on a company you are looking at
Meridian Trace puts over 2 million device registrations across 31 markets in one workspace, with each company's license holders, predicates and competitors beside them. Send us one company and we'll show you.
See how it works for investors →What the checks do not tell you
The registries show what was approved, where, when and through whom. They do not show whether the device works, whether clinicians will use it, or whether the company can sell. Regulatory diligence will not make the investment case. It tells you whether the regulatory line in the deck is true, and what it will cost to make the next one true.