62% of medical device types are classified differently depending on the market. Here is the data, and what it means for a submission plan.
Of 1,525 device types registered in at least four comparable markets, 945 — 62% — carry a different risk class in at least one of them. A dental implant system is a high-risk device in Brazil, Canada, China, Mexico and Taiwan, a medium-risk device across the EU and most of Asia, and a low-risk device in South Korea. Same device, same GMDN term, three different regulatory burdens.
This is not published anywhere, because it is not any single registry's fact. Each authority states its own classification; none of them states how that compares to the others. It only becomes visible by observing the same device type across many registries at once, which is what Meridian Trace does.
Risk class drives the submission route, the evidence package, the review timeline and often whether a local clinical evaluation is required. A plan built on the assumption that a device's EU class carries into Brazil or China is a plan that discovers a heavier dossier late, when the timeline no longer has room for it.
The direction is not consistent either, which is what makes it hard to intuit. Brazil is stricter than the EU for catheters and femoral nails, and less strict for external fixation systems. Australia and the UK sit low on orthopaedic fixation while China sits high. There is no reliable rule of thumb to substitute for looking.
Every row below is registered in at least four markets, with at least 15 registrations and 60% agreement per market. Ranked by how far apart the classifications sit.
The same data is queryable for any device type, by GMDN code, GMDN term, or FDA product code. From an AI agent over MCP, or directly:
curl -s https://meridiantrace.com/v1/mcp \ -H "X-API-Key: YOUR_KEY" \ -H "content-type: application/json" \ -d '{"jsonrpc":"2.0","id":1,"method":"tools/call", "params":{"name":"classify_device", "arguments":{"device_type":"Dental implant system"}}}'
It returns the GMDN hierarchy, the FDA product codes the type maps to, and the observed risk class in every market where we hold enough records to say — each with the sample size behind it. A free key takes about a minute at meridiantrace.com/api.
These are observed classifications, drawn from the risk class recorded on actual registration records in each market, not from reading each country's classification rules. For every device type and market we report the modal class, the share of records agreeing with it, and the number of records it was drawn from. A market showing n=15 is a hint; n=3,000 is a pattern. Both travel with the answer so you can tell them apart.
That makes this a good way to find out where your assumptions are likely wrong, and a poor substitute for a regulatory determination. Registries also differ in how they name classes, which we normalise to Low / Medium / High — a normalisation that is useful for comparison and lossy at the edges. Confirm against the market's own classification rules before you file.
Data as of 20 August 2026, drawn from 1.9M registration records across 36 national registries. Coverage and per-registry crawl dates are queryable via the get_coverage tool.
get_coverage