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“Approved in Australia.” “Registered in Europe.” “Certified for the US.” Suppliers make market-specific claims constantly, and buyers rarely check them — partly because most people do not know that many of these registers are public and searchable. This hub explains what can actually be verified in each of ten markets, and covers the finding that surprises buyers most: a device missing from a national register is frequently not evidence of a lie. It often means the product was never placed on that market as a regulated medical device at all — which is a different fact, with different implications.
RedVance manufactures red light therapy panels in Shenzhen and supplies brands selling into most of these markets, so we deal with these claims from the supply side. This hub is the method and the map; each market has its own guide with the specific register, identifier and pitfalls.
Three questions before you search anything
Buyers usually jump straight to a database and get a confusing result. Ask these first:
- Which market, precisely? “Europe” is not a market for this purpose — the EU and the UK are separate regimes with separate systems.
- Which regulatory category? Is the supplier claiming the device is a regulated medical device in that market, or something else — a general consumer electrical product, a wellness product, an electrical-safety conformity claim? This determines which register, if any, applies.
- What identifier? A clearance number, licence number, registration number, or listing number. A supplier who claims a status but cannot produce an identifier has largely answered the question.
What “not found” actually means
| Scenario | What absence from a register means |
|---|---|
| Sold as a general wellness / consumer product | Expected. It was never registered as a medical device — not a red flag |
| Device class exempt from registration | Expected. Canada’s MDALL covers Class II–IV; Class I devices do not appear. Singapore exempts Class A from registration |
| Registered under a different entity name | Search the importer, distributor or local representative — they are often the registrant, not the factory |
| Supplier explicitly claimed registration or approval there | This is the case where absence matters. Ask for the identifier in writing |
The distinction in the last row is the whole point of this hub. Verification is not about catching people out — it is about establishing what is actually true, so your listing claims match reality in the market where you sell.
Registration is not endorsement
One trap repeats across markets, and at least one regulator prohibits it in writing.
The UK’s MHRA states that registration of medical devices with the MHRA does not represent any form of accreditation, certification, approval or endorsement, and that claims to that effect — including use of MHRA logos in marketing materials, on packaging or in instructions for use — are not permitted.
This is structurally identical to the US distinction between FDA registered (an administrative listing, no review) and FDA cleared (a specific device reviewed for a specific indication) — covered in our FDA 510(k) verification guide and our claims verification guide.
The ten markets
Each guide covers who regulates, what is publicly checkable, how to search it, and what the local pitfalls are.
North America
- United States — FDA. Public 510(k) and establishment registration databases; the cleared-versus-registered distinction dominates.
- Canada — Health Canada. The Medical Devices Active Licence Listing (MDALL) covers Class II, III and IV; Class I devices are handled through establishment licensing and do not appear.
Europe
- European Union — no single approving authority for most products. Verification centres on the Declaration of Conformity, notified body identity where one is involved, and what CE marking does and does not signify.
- United Kingdom — MHRA, with its Public Access Registration Database (PARD) and the explicit rule that registration is not endorsement.
Asia-Pacific
- Australia — TGA. The Australian Register of Therapeutic Goods (ARTG) is public, and therapeutic claims are what pull a product into scope.
- Singapore — HSA. The Singapore Medical Device Register (SMDR) is publicly accessible through HSA’s e-services; Class A devices are exempt from registration.
- Malaysia — the Medical Device Authority, under the Medical Device Act 2012.
Latin America
- Brazil — ANVISA, with a local registration holder requirement for foreign manufacturers, and additional certification requirements for electrical products.
- Mexico — COFEPRIS, with reliance pathways that consider approvals from recognised reference authorities.
Reliance pathways: why an approval elsewhere is not an approval here
Several regulators operate reliance or abridged routes that take account of an existing authorisation from a designated reference regulator. Singapore’s HSA, for example, offers abridged evaluation for devices already approved by reference agencies, and Australia’s TGA accepts specified forms of overseas manufacturer evidence when assessing ARTG applications.
Two consequences for a buyer:
- An approval elsewhere can accelerate a local application — it does not replace one. “It’s FDA cleared, so it’s fine for Australia” is not how any of these systems work.
- These pathways are why suppliers conflate markets. A supplier who genuinely holds one authorisation may speak loosely about others, without intending to deceive. Ask per market, per identifier.
The practical market-by-market differences in markings, plugs and documentation are in our market comparison guide.
The four questions that work anywhere
- “In which market, and under which regulatory category?”
- “What is the registration, licence or clearance number?”
- “Which legal entity holds it?” — often the local representative or importer, not the factory. Entity matching is covered in our business registration verification guide.
- “What is the stated intended use on the record?” — a registration covers a specific purpose, not the product in general.
Then search the market’s register with that identifier. If the record exists and matches on all four points, the claim is substantiated for that market. If the supplier cannot supply the identifier, the claim is unsubstantiated regardless of how confidently it is stated.
Regulatory status is only one axis of verification. It says nothing about whether the panel delivers its claimed output — a separate question with separate evidence, covered in our guide to reading an irradiance test report, our certification verification guide, and our guide to verifying a supplier is a factory. Terms are defined in our glossary.
What a manufacturer can do about it: state per market what exists and what does not, name the exact category a product is sold under rather than implying a medical device status it does not hold, provide identifiers without being pressed, and tell buyers plainly when a device is outside a regulatory framework in a given market. Suppliers who make their status easy to check are the ones with nothing to lose from checking.
Frequently asked questions
How do I verify a supplier’s regulatory claim for a specific market?
Ask three questions first: which market, which regulatory category, and what identifier. Then search the relevant public register for that market using the identifier the supplier provides. Confirm the record names the same legal entity and the same device model, and read the stated intended use, because a registration covers a specific purpose rather than the product generally.
What does it mean if a device is not in a country’s medical device register?
Often it means the device was never placed on the market as a regulated medical device in that country, which can be entirely legitimate. Many light-emitting wellness products are sold outside medical device frameworks. Absence from a register only indicates a false claim when the supplier specifically asserted that the device is registered or approved as a medical device there.
Which markets publish searchable medical device registers?
Several major markets publish public registers, including the United States through FDA databases, the United Kingdom through the MHRA Public Access Registration Database, Australia through the ARTG, Canada through the Medical Devices Active Licence Listing, and Singapore through the Singapore Medical Device Register. Public access varies by market and by device class.
Does registering a device with a regulator mean the regulator endorsed it?
No, and some regulators state this explicitly. The MHRA notes that registration of medical devices with it does not represent accreditation, certification, approval or endorsement, and that claims to that effect are not permitted. Registration and substantive review are different things, and suppliers sometimes present the first as though it were the second.
Do low-risk devices appear in these registers at all?
Frequently not. Canada’s MDALL covers Class II, III and IV devices, and Class I devices do not appear in that listing. Singapore exempts Class A devices from registration. So a low-risk device may be legitimately on the market while being absent from the register a buyer searches.
Does an approval in one market carry over to another?
Not automatically. Some regulators operate reliance or abridged pathways that consider approvals from designated reference regulators, which can shorten a process, but that still requires an application in the destination market. A clearance or registration in one country never by itself authorises sale in another.
Ask us what exists in your market, and what does not
Tell us where you intend to sell. We will tell you specifically which documentation we can provide for the device, what category it sits in, and where your regulatory pathway begins — including where the honest answer is that nothing is registered. Smaller verifiable statements beat larger vague ones.
Ask about a specific market →