How to verify a medical-device manufacturer or distributor: FDA, EUDAMED, SFDA and JFDA checks

Published 2026-11-14 · By Ala'a from The Biomedical Index · اقرأ بالعربية

To verify a medical-device manufacturer or distributor, check the official regulator databases for each market you buy or sell in, not the company's own website or a PDF certificate. In the United States that means the FDA Establishment Registration & Device Listing database plus the 510(k) or PMA databases. In the European Union it means EUDAMED. In Saudi Arabia it means the SFDA Medical Equipment List and the SFDA licensed establishments list, and in Jordan it means the JFDA Directorate of Medical Devices and Supplies. Then confirm the quality system (ISO 13485) and the distributor's written authorisation.

This guide is written for hospital buyers, biomedical engineers, importers and distributors, with a focus on the Middle East. Every regulator database below is free to search. The directory links point to the matching entries on The Biomedical Index, so you can open the regulator, standard or company directly.

1. Start with the company's role

Before you search anything, write down who is who in the deal:

• Legal manufacturer: the company whose name is on the label and that holds the marketing authorisation.
• Authorised representative or local registration holder: the local company that holds the device registration in a given country.
• Importer or distributor: the company that brings the product in and sells or services it.

Regulator databases are searched by these names, so a mismatch between the quotation, the label and the registration record is your first warning sign.

2. United States: FDA registration is not approval

Companies that produce or distribute devices for the US market must register their establishment with the FDA every year and list the devices made there (FDA, Device Registration and Listing). You can search the public Establishment Registration & Device Listing database, which the FDA says is updated weekly, usually every Monday. A single search returns at most 100 establishments, so search by part of the name if you get nothing.

The key point many buyers miss: US regulation says that registration of an establishment, or holding a registration number, "does not in any way denote approval of the establishment or its products", and presenting it as approval is misbranding (21 CFR 807.39). A supplier who sends an "FDA registration certificate" as proof of approval is showing you the wrong document.

What you actually want is the device's marketing authorisation. For most devices that is a 510(k) clearance: the FDA issues an order finding the device substantially equivalent to a legally marketed device, which "clears" it for sale (FDA, Premarket Notification 510(k)). Search the 510(k) database by applicant or device name, and the PMA database for high-risk devices. Some Class I and II devices are exempt from 510(k), so "no 510(k)" is not automatically a red flag; check the exemption for that device type.

In the directory: FDA CDRH, FDA 510(k) database, FDA MAUDE (adverse event reports) and FDA QMSR (21 CFR Part 820).

3. European Union: check EUDAMED

EUDAMED is the European database on medical devices set up under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). According to the European Commission, four of its modules became mandatory to use on 28 May 2026: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance (European Commission, EUDAMED overview).

For a supplier check, that means you can use the public EUDAMED site to look up the manufacturer as a registered actor, find its devices, and see the certificates issued by its notified body. Make sure the certificate number, the notified body and the device on the quotation all match the record. You can look up the notified body itself in the Commission's notified bodies database (NANDO), part of the Single Market Compliance Space.

In the directory: EUDAMED, European Commission medical devices, and notified bodies and certification bodies such as BSI, TÜV SÜD, TÜV Rheinland and DEKRA.

4. Saudi Arabia: SFDA Medical Equipment List

The Saudi Food and Drug Authority answers the question "how can I check if a product has marketing permission?" directly: use its medical equipment list, or email md.rs@sfda.gov.sa with the manufacturer name, brand name and model (SFDA FAQ).

The SFDA Medical Equipment List can be searched by brand name, manufacturer name and authorisation number. Its records include the device classification, the authorised representative, the expiry date and the status (SFDA, Medical Equipment List). Two checks matter most: the status is active and the expiry date has not passed, and the authorised representative is the company you are actually dealing with, or has authorised it in writing.

For a distributor or importer, also look the company up in the SFDA licensed establishments list.

In the directory: SFDA, SFDA Medical Equipment List, SFDA licensed establishments list, and biomedical companies in Saudi Arabia.

5. Jordan: JFDA Directorate of Medical Devices and Supplies

In Jordan, medical devices are regulated by the Jordan Food and Drug Administration through its Directorate of Medical Devices and Supplies. JFDA says the directorate became a separate directorate in 2012, and that its tasks include registering imported and locally produced medical devices and supplies under the 2019 instructions for importing and trading medical supplies, issuing free-sale certificates for local exports, and sampling products on the market for laboratory testing (JFDA, Directorate of Medical Devices and Supplies, in Arabic).

JFDA also runs an online enquiry service for approved and registered medical devices and supplies (JFDA device enquiry, in Arabic). Ask the Jordanian supplier for the registration details of the exact model, then confirm them there or with the directorate.

In the directory: JFDA and biomedical companies in Jordan.

6. Confirm the quality system: ISO 13485

ISO 13485:2016 is the international standard for quality management systems in the design and manufacture of medical devices. ISO lists it as the current edition and says it was last reviewed and confirmed in 2025 (ISO 13485:2016). Ask for the certificate, check that its scope covers the products you are buying and the site that makes them, note the expiry date, and confirm the certificate with the body that issued it.

In the directory: ISO 13485, ISO 14971 (risk management) and IEC 60601 (medical electrical equipment).

7. For distributors: authorisation and service

• Ask for a current, signed letter of authorisation from the legal manufacturer that names the distributor, the territory and the product range, and confirm it with the manufacturer directly.
• Check that the distributor (or a named service partner) can install, maintain and calibrate the equipment, with trained engineers and access to spare parts.
• Check that the distributor's name matches the local registration holder in the regulator record, or that it has written authorisation from that holder.

Browse distributors and marketplaces, service and parts and test and calibration companies in the directory.

Quick checklist

The Biomedical Index lists regulators, standards bodies and companies in one place. Start from Regulatory & Standards, Manufacturers or browse by country.

Facts are taken from the official sources linked in the text as of the publication date. Rules and lists change, so always confirm with the regulator before a purchase or registration decision.