The Tool Desk
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What information do you need before checking a market?
Start with the IVD as it will actually be offered for sale. A product name such as “test kit” is not enough to establish its regulatory classification or route to market. Record the exact intended purpose and claims, including the target analyte or condition and the meaning of a positive, negative, or indeterminate result.
- Specimen type and collection method.
- Intended user and setting: for example, a laboratory professional, point-of-care user, or person performing a self-test.
- Every component included in the offer: instrument, assay, calibrator, control, accessory, software, or related service.
- Relevant software dependencies, product models, manufacturing sites, and the precise claims made on labels, instructions for use (IFU), and promotional materials.
Classification is market-specific. The Australian Therapeutic Goods Administration (TGA) says intended purpose and risk underpin classification and that the manufacturer is responsible for classification. A change to the intended user, setting, components, or claims can therefore affect the analysis; do not assume that the same kit name or class applies in every destination.
How do you verify requirements country by country?
- Name each destination. List countries and territories rather than relying on “allied countries.” Treat the European Union, Great Britain, and Northern Ireland as separate destinations where relevant.
- Find the current official route. Use the destination regulator’s current IVD guidance and applicable legislation to establish the product class, authorization or conformity-assessment route, whether third-party review applies, required technical and performance evidence, and any registration or listing steps.
- Separate obligations by purpose. Identify product market authorization, establishment registration, device listing, quality-system requirements, and local representative, sponsor, or importer obligations separately. A registration or audit is not necessarily product authorization, and one obligation does not automatically satisfy another.
- Confirm who is legally responsible locally. Identify the required representative, sponsor, importer, or establishment licence holder. Check the role’s statutory responsibilities rather than assuming a distributor fills every required role.
- Verify the official record. Search the regulator’s database where available and match the legal manufacturer, device name and model, class, authorization number, intended purpose, certificate scope, manufacturing sites, and validity dates to the product you intend to supply.
- Check supply and post-market rules. Confirm applicable language and label/IFU requirements, traceability or UDI obligations, complaint handling, incident reporting, field-action procedures, and change-notification rules.
- Keep a dated market file. Record the source and date of each check, retain database extracts or screenshots, assign a vigilance contact, and set a review date. Recheck before launch and after changes to the product, claims, sites, local partner, or applicable rules.
What do the main market examples require you to check?
| Destination | What to verify | Key distinction |
|---|---|---|
| United States | Determine applicable FDA requirements for the specific IVD, including whether premarket authorization is required, as well as registration/listing, quality-system, labeling, and reporting obligations. | FDA says it does not recognize regulatory authorizations from other countries as a substitute for U.S. requirements. Registration is not device authorization; registration and listing alone do not permit marketing when premarket authorization is required. (FDA, “Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S.” and “Overview of IVD Regulation.”) |
| Great Britain | Check MHRA registration before placing a medical device, including an IVD, on the market. A manufacturer based outside the UK must appoint a UK responsible person, who handles registration and specified tasks. | Great Britain remains under UK MDR 2002 with transition provisions. MHRA guidance lists CE-mark transition provisions, including certain EU IVDR-compliant IVDs through 30 June 2030 and certain EU IVDD-compliant IVDs until the earlier of certificate expiry or 30 June 2030. Eligibility and exceptions depend on the current guidance; verify the exact product before relying on a transition. (MHRA, “Regulating medical devices in the UK,” last updated 20 February 2026.) |
| Northern Ireland and EU Member States | Check the applicable EU IVDR requirements and the product’s route in the specific destination. | EU IVDR has applied in EU Member States and Northern Ireland since 26 May 2022. Do not assume Great Britain’s route or transition provisions apply there. (MHRA, “Regulating medical devices in the UK.”) |
| Australia | Verify classification and conformity evidence, identify the Australian sponsor, and confirm the required Australian Register of Therapeutic Goods (ARTG) entry before import or supply. | The sponsor is the person or company legally responsible for supply. The TGA says devices generally must be entered in the ARTG before lawful supply or import; certain self-testing IVDs are currently prohibited from supply, making intended use material. TGA guidance version 2.1, dated April 2026, describes specified foreign evidence it may consider in its assessment, including certain FDA, Health Canada, EU, and Japanese approvals. This is an assessment route, not blanket mutual recognition. (TGA, “Overview of medical devices and IVD regulation” and “Use of market authorisation evidence from comparable overseas regulators for medical devices (including IVDs).”) |
| Canada | For commercial imports, determine the device class, whether a medical device licence (MDL) is required, and whether the importer needs a medical device establishment licence (MDEL). Verify applicable exemptions and check active licence records. | Class II, III, and IV devices generally require an MDL; Class I devices generally do not. The importer generally needs an MDEL covering import activity, subject to exemptions. Health Canada provides active device-licence and establishment-licence databases. (Health Canada, “Regulatory requirements for importing medical devices.”) |
| Japan | Use official Japanese regulatory information to research the IVD’s local authorization route and applicable obligations. | FDA’s MDSAP international-regulations resource points to Japan’s PMDA information. That pointer is not a product authorization. MDSAP is an audit program, not permission to market an individual device. (FDA, “MDSAP International Regulations [English].”) |
Can an FDA decision or CE mark be used in another market?
Only where the destination regulator’s current rules permit the evidence to be used, and only subject to that regulator’s conditions. Do not present an authorization in one jurisdiction as automatic approval in another. FDA expressly says foreign country authorizations are not a substitute for applicable U.S. rules. In Australia, the TGA’s April 2026 guidance identifies specific comparable-overseas-regulator evidence it may consider, but the TGA still assesses the application under its own framework.
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Likewise, an audit certificate should not be confused with permission to sell a particular IVD. FDA’s MDSAP resource covers participating jurisdictions including Australia, Brazil, Canada, Japan, and the United States; MDSAP is an audit program. Use it as an aid to quality-system audit planning, not as proof that the product has the required local authorization.
How do you check an IVD or importer licence?
Use the destination regulator’s official database, not a distributor’s statement or a certificate image by itself. In Canada, Health Canada provides active databases for device licences and establishment licences. Check the device and the relevant importer record separately where applicable.
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For each record, compare the legal entity and product details against your planned supply. A licence for a different model, manufacturer, site, intended purpose, or activity may not establish that the product or importer in your transaction is covered. Save a dated extract or screenshot with the market-entry file and note any mismatch for resolution with the responsible party or regulator.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What belongs in a market-entry matrix?
Use one row per country or territory, with fields that make omissions visible before a launch decision:
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- Intended purpose and claims reviewed for that destination.
- Product classification and the basis for it.
- Applicable regulation and version checked.
- Authorization route, required evidence, and certificate or decision status.
- Legal manufacturer and covered manufacturing sites.
- Local responsible person, sponsor, importer, or establishment licence holder and their roles.
- Label and IFU version, language, and required local details.
- Official database or record checked, the date, and the result.
- Vigilance contact, reporting process, change-control obligations, and next review date.
Review volatile transition provisions and authorization status close to launch, not only when planning begins. No single “allied-country” pathway or universal approval timeline can replace this destination-by-destination check.
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