A customer sends you a certificate and asks whether it is genuine. A tender requires the registration certificate for the target market. A manager asks whether a competitor really holds a certificate in Saudi Arabia. All three sound like a quick search online, yet most people get the first step wrong: they query the wrong database.
This guide lists the official lookup portals for 30 major medical device markets in one place and flags the five markets where verification most often goes wrong. Every link sits on a regulator-owned domain and was checked on 4 November 2026.
1. Three ground rules before the list
Unless these three rules are clear, the 30 links below will still be used the wrong way.
Rule 1: three types of database are not interchangeable
A regulator runs more than one database, and their evidential value differs completely:
| Type of database | What it proves | Typical examples |
|---|---|---|
| Product registration and licensing database | A specific model is cleared for sale in a given market | FDA 510(k), EUDAMED, NMPA data query |
| Establishment and site licensing database | A company holds an operating authorisation | FDA establishment registration and device listing, South Africa SAHPRA |
| Adverse event and recall database | Post-market safety information, unrelated to registration status | MAUDE, DAEN |
The most common error: a company can be found in the FDA establishment registration database, so its products are assumed to have cleared FDA. Establishment registration and device listing only show that the company is entitled to sell into the United States; they say nothing about whether any model has obtained a 510(k).
Rule 2: a record exists does not mean it is still valid
Many records in official databases are historical archives. Canada MDALL has a separate Archived Licences search for historical licences; the Brazil ANVISA status field distinguishes Valido (valid) from Invalido (invalid); Korea shows Normal or Cancelled; Hong Kong shows Valid, or Expired or Delisted.
When reading a record, the status field and the expiry date must both be checked. Looking only for the presence of a name is not a verification.
Rule 3: no record does not mean no registration
This is the most expensive mistake in practice. A failed search has at least five explanations:
- The system never required product-by-product registration (Hong Kong’s voluntary listing; South Africa issues establishment licences only).
- The database does not cover this type of product (Canada does not license Class I devices; Singapore Class A devices are not in SMDR).
- A transition period is still running (EUDAMED, Switzerland swissdamed, Chile Decree No. 25).
- The product name or number is written differently (local language, spaces and hyphens, brand name versus generic name).
- There is genuinely no record.
The first four are not cases of an unregistered device. Unregistered is a legal conclusion that only a document issued by the regulator or by the licence holder can support. It cannot be inferred from a failed search.
2. North America
| Market | System | Official portal | What you can find |
|---|---|---|---|
| United States | 510(k) premarket notification (FDA) | accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm | K number, applicant, device name, product code, decision date |
| United States | PMA, Class III (FDA) | accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm | P number, supplements |
| United States | Establishment registration and device listing (FDA) | accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm | Registration number, owner/operator, registered address |
| United States | Product classification database (FDA) | accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm | Class and 21 CFR section for a product code, and whether a 510(k) is required |
| Canada | MDALL (Health Canada) | health-products.canada.ca/mdall-limh/ | Valid Class II/III/IV licences; a separate archived licence search is also available |
| Mexico | Visor de Registros Sanitarios (COFEPRIS) | registros.cofepris.gob.mx/BRSDM | Registration number, product description, titular (licence holder) |
Canada note: Class I devices are not issued a product licence, so a missing licence is normal; the MDEL certificate can be checked instead. Mexico note: the viewer went live only on 20 August 2026 (press release 21/2026) and the data is still being validated by licence holders, so coverage must be monitored.
3. Europe
| Market | System | Official portal | What you can find |
|---|---|---|---|
| European Union | EUDAMED public site (European Commission) | ec.europa.eu/tools/eudamed | Economic operator SRNs, devices and SPPs, certificates including rejected ones, notified bodies, EMDN |
| European Union | Notified body directory, formerly NANDO | webgate.ec.europa.eu/single-market-compliance-space | Designated scope of each notified body (MDR / IVDR / legacy directives) |
| United Kingdom | PARD (MHRA) | pard.mhra.gov.uk | Registered manufacturers, device trade names, GMDN, registration status |
| Switzerland | swissdamed (Swissmedic) | swissdamed.ch | Economic operator CHRN, role type, UDI devices |
| Russia | State Register of Medical Devices (Roszdravnadzor) | roszdravnadzor.gov.ru | RU registration number, validity, authorised representative, manufacturing address, change history |
The standard test for a CE certificate: the four-digit NB number on the certificate must appear in the notified body directory, and the designated scope must cover the class of the device and the applicable regulation. Confirming that the NB number exists without confirming its scope is the most common missed step.
The EUDAMED trap: the first four modules became mandatory for economic operators on 28 May 2026, but during the transition many devices covered by legacy MDD/AIMDD certificates have not yet been registered. When a search fails, verify against the notified body’s own certificate database rather than concluding that no certificate exists.
A counter-intuitive fact about the United Kingdom: many people assume MHRA has no public database, yet PARD is publicly searchable. MHRA states clearly, however, that registration is not an approval, certification or endorsement and must not be used for promotion.
4. Asia-Pacific
| Market | System | Official portal | What you can find |
|---|---|---|---|
| China | NMPA data query, medical devices | datasearch.nmpa.gov.cn | Domestic and imported device registration and filing, including historical records, manufacturer licences and distributor licences |
| Hong Kong, China | MDACS listed device search (Medical Device Division) | mdd.gov.hk/tc/mdacs/search-database/list-md/ | HKMD number, class, local responsible person, model, status |
| Taiwan, China | Western drug and medical device licence search (TFDA) | lmspiq.fda.gov.tw/web/ | Licence number, approved indications, licence holder; low-risk devices carry a separate registration number |
| Japan | Medical device information search (PMDA) | pmda.go.jp/PmdaSearch/kikiSearch/ | Approval or certification number, marketing name, generic name, review report PDF |
| Korea | Medical device information portal, emedi (MFDS) | emedi.mfds.go.kr/search/data/MNU20237 | Product approval, certification or notification, approval date, class, status, validity |
| Australia | ARTG (TGA) | tga.gov.au/resources/artg | ARTG ID, listing status, sponsor, product information |
| New Zealand | WAND (Medsafe) | medsafe.govt.nz | Device notification records; no public full-text search; WAND requires a five-digit sponsor ID to log in |
China note: the format of the number tells you the certificate type quickly. A national Class III certificate uses the Zhuzhun wording with the Guo prefix, a provincial Class II certificate uses the same wording with a provincial prefix, imported devices use Zhujin, and filings use Bei. If the product name or registrant returned for the number printed on the label does not match the device in hand, treat it as suspect.
Australia note: an ARTG entry is held by the Australian sponsor, not by the manufacturer. Changing distributor may require a new listing, which makes Australia a classic case of a new agent needing a new certificate.
Korea note: the old search address no longer works; use the path above.
5. Southeast Asia
| Market | System | Official portal | What you can find |
|---|---|---|---|
| Singapore | SMDR and Class A database (HSA) | share.hsa.gov.sg/medics/PublicListing/Smdr | Registration number, intended use, risk class, registrant, models; Class A devices are searched separately by notification number |
| Malaysia | MDA public search | mdar.mda.gov.my | Device registration status, establishment licence of the supplier |
| Thailand | FDA Search Center (Thai FDA) | porta.fda.moph.go.th/FDA_SEARCH_ALL/ | Registration number, product name, manufacturer, importer |
| Indonesia | InfoALKES (Ministry of Health) | infoalkes.kemkes.go.id | Distribution licence (izin edar), product name, manufacturer, registrant |
| Vietnam | Medical device management online public service system (IMDA) | imda.moh.gov.vn | Class A/B declaration number, Class C/D circulation registration number |
| Philippines | FDA Verification Portal | verification.fda.gov.ph | CPR product registration certificate, CPN notification certificate, LTO operating licence |
Singapore note: the two databases must be searched separately. Searching only SMDR misses a large number of low-risk products; conversely, a Class A entry is not an HSA endorsement. In 2026 the Philippines FDA moved to a single verification portal for unified searching (FDA issuance 2026-0106) and supports export to Excel, CSV or PDF as compliance evidence.
Indonesia note: device certificates are issued by the Ministry of Health and are not held in the BPOM system, so a search of BPOM is wasted effort.
6. South Asia, the Middle East, South America and Africa
| Market | System | Official portal | Key features |
|---|---|---|---|
| India | MD Online list of approved devices (CDSCO) | cdscomdonline.gov.in/NewMedDev/ListOfApprovedDevices | Licence number, legal entity, brand and authorised models, issuing authority |
| Saudi Arabia | Medical Equipment List (SFDA) | sfda.gov.sa/en/medical-equipment-list | The most complete database in the Middle East: authorisation number, MDMA Listing No., authorised representative, validity, GMDN |
| United Arab Emirates | Registered Medical Product Directory (MOHAP) | mohap.gov.ae | Federal-level registration directory |
| Turkey | UTS product tracking system (TITCK) | uts.titck.gov.tr | Registration and traceability, UBB barcode |
| Israel | Medical Devices Registry (Ministry of Health) | registries.health.gov.il/MedicalDevices | Registration number, product name, manufacturer |
| Brazil | Consultas, Produtos para Saude (ANVISA) | consultas.anvisa.gov.br | Registration or notification number, technical name, holder CNPJ, status |
| Colombia | Consulta Registro Sanitario (INVIMA) | consultaregistro.invima.gov.co | Validity of the registration number, holder |
| Argentina | HELENA, Boletin (ANMAT) | helena.anmat.gob.ar/Boletin/ | Notices of issued registrations, registration numbers |
| Chile | Registro Sanitario (ISPCH) | registrosanitario.ispch.gob.cl | Sanitary registration and background review records |
| Peru | DIGEMID device sanitary registration | digemid.minsa.gob.pe/rsDispositivos/ | Device sanitary registration |
| South Africa | Medical Devices Licences Issued (SAHPRA) | sahpra.org.za/medical-devices-licences-issued/ | Establishment licences only |
UAE note: Dubai (DHA / EDDE) and Abu Dhabi (DOH) run separate registration systems. When the federal database has no record, the emirate-level licence must be verified separately.
Turkey note: the rules are closely aligned with EU MDR but registration is separate; a CE certificate is a prerequisite, not a substitute.
7. The five markets most often checked wrongly
This section is the most valuable part of the guide.
Q1 If Hong Kong has no record, does that mean the device is not registered?
No. Hong Kong operates a voluntary listing scheme (MDACS), not mandatory registration.
Not being listed is not automatically unlawful. In practice, however, procurement by the Department of Health and the Hospital Authority already gives priority to listed devices, and the Hospital Authority has done so since 2024. For Hong Kong, listing therefore determines access to public procurement, not legality.
Q2 Why is there no product certificate to find in South Africa?
Because South Africa does not issue product registration certificates at all.
The SAHPRA Medical Devices Licences Issued database contains establishment-level licences for manufacture, import, distribution and wholesale. It proves that a company is licensed; it does not prove that a specific model is registered. Using it as evidence that a product is registered is the wrong direction entirely. For product-level confirmation, write to mdenquiries@sahpra.org.za.
Q3 Why is there no public lookup for New Zealand?
Because WAND is open to sponsors only.
WAND (Web Assisted Notification of Devices) requires a five-digit sponsor ID to log in, and there is no public full-text search. Only two alternatives exist: check the Medsafe recall and alert pages, or ask the supplier for a screenshot of the WAND notification. Note also that New Zealand does not perform pre-market technical review, so notification is not approval.
Q4 Why does the old Korean link no longer open?
Because MFDS has moved the search address.
The old address is dead; the current path is emedi.mfds.go.kr/search/data/MNU20237. Portals move frequently in Southeast Asia and the Middle East, and most bookmarked links will eventually break.
Q5 Why is the Mexican database incomplete?
Because it only went live on 20 August 2026.
The COFEPRIS device registration viewer (Visor de Registros Sanitarios de Dispositivos Medicos) was launched under press release 21/2026. It lists only vigente (valid) registrations, and the data is still being validated by licence holders. A failed search is not proof that no registration exists; the original certificate provided by the holder must also be taken into account.
Three more frequent misreadings
United States: establishment registration and device listing are not a 510(k). See Rule 1.
Singapore: SMDR and the Class A database are two separate systems, and low-risk products are most likely to appear only in the Class A database.
Argentina: since 2025 some Class I and Class II devices have moved to the sworn declaration route under Disposicion 8799/2025, with no fixed validity period and changes to be re-filed within 30 days. No certificate does not mean not authorised.
8. After you find a record, check these two fields
Field one: status
| Market | Status field | Meaning |
|---|---|---|
| Brazil | Valido / Invalido | Valid / invalid |
| Korea | Normal / Cancelled | Valid / cancelled |
| Hong Kong, China | Valid / Expired or Delisted | Listing status |
| European Union | Certificate status plus rejected records | Must be read at notified body level |
| Mexico | Only vigente listed | The database holds valid records only |
Field two: the licence holder
This is the most overlooked column and the one with the heaviest commercial consequences. In Mexico, Brazil, Vietnam, Korea, Australia, Israel and Saudi Arabia the certificate usually sits with a local holder rather than with the manufacturer: titular in Mexico, the CNPJ holder in Brazil, the sponsor in Australia, the authorised representative in Saudi Arabia.
What this means for manufacturers: changing distributor may mean registering again. At the negotiating table, who holds the certificate directly determines bargaining power.
9. Four standard steps when nothing is found
Work through them in order; do not skip a step:
- Confirm the type of system in that market first, since product-by-product registration may never have been required.
- Switch to local-language keywords: Japanese, Korean, Thai, Indonesian, Vietnamese, Spanish and Portuguese produce very different hit rates. Numbers must be entered exactly, including spaces and hyphens.
- Search by company name: most databases allow a reverse search of every product registered to a manufacturer or holder. This is far more effective than guessing product names, and it is the correct way to run a competitor scan.
- Write formally: send an official enquiry to the relevant department of the regulator and keep the reply as due-diligence evidence. Common addresses are md.rs@sfda.gov.sa for Saudi Arabia and mdenquiries@sahpra.org.za for South Africa.
10. Turn it into a deliverable
Scattered links only carry commercial value when they are used as a system. Our internal template uses four fixed columns: market, lookup system and link, what was found (certificate number, status, holder), and date of search. Gaps are recorded as not found, never as a dash and never as a guess.
When comparing several markets, add a confidence column: high when an official database returns a direct hit with consistent fields; medium when there is a hit but the holder name differs; low when there is no hit at all, which requires a written enquiry.
Disclaimer: this article is compiled from information published by each regulator and was checked as of 4 November 2026. It is provided for general industry reference only and does not constitute legal advice. Regulators revise their portals frequently, so confirm that each entry is live and record the date of your search before citing it. The registration status of a specific product should be confirmed against the original certificate or an official written reply from the regulator.