Tender files for laryngoscopes look much the same everywhere, but the documents behind them depend on the market. This checklist sets out what hospital and government buyers typically ask a manufacturer for, why, and how to check each item at its source. Rules change, so confirm current requirements with the relevant authority.
Documents for every market
ISO 13485 certificate
ISO 13485 is the quality management system standard for medical devices; a certificate shows that a certification body has audited the manufacturer’s system. Check that the scope covers the products offered, and check the factory address, the expiry date and who accredits the certification body. FDA’s quality management system regulation has incorporated ISO 13485 by reference since February 2026, but FDA does not issue ISO 13485 certificates, and a certificate does not replace an FDA inspection.
Instructions for use and labelling
Buyers ask for the instructions for use (IFU) in the languages the market requires, and for samples or artwork of the device, unit pack and carton labels. Names, codes, symbols and UDI should match the declarations and registrations.
Test reports
Reports should support the claims made: for example conformity with ISO 7376, biocompatibility under the ISO 10993 series, reprocessing validation for reusable devices, sterilisation validation for sterile devices and electrical safety for handles where it applies. Check that the samples tested match the products offered. Government buyers may also ask for a certificate of free sale.
European Union
Under the Medical Device Regulation (EU) 2017/745 (MDR), buyers usually ask for:
- EU Declaration of Conformity. The manufacturer’s signed statement that the listed devices meet the MDR, giving its Single Registration Number (SRN), the devices and their Basic UDI-DI, their risk class, and any notified body and certificate involved.
- Notified-body certificates, where the class requires them. Class IIa and above need one. For class I, a notified body is involved only for specific aspects, such as sterility; otherwise the manufacturer self-declares and the CE marking carries no number. A “CE certificate” from a body that is not an MDR notified body has no standing under the regulation.
- EUDAMED actor registration. Manufacturers, EU authorised representatives and importers register in EUDAMED, the European database on medical devices, and receive an SRN. A manufacturer outside the EU must appoint an authorised representative, who is named on the label.
- UDI. Devices carry a unique device identifier on the label; reusable devices reprocessed between patients must also carry it permanently on the device, subject to exceptions and class-dependent dates.
Four EUDAMED modules, for actors, devices, certificates and market surveillance, became mandatory in May 2026, so more can now be checked directly. Documents under the old Medical Device Directive (MDD) need explaining, because the transitional rules cover only certain devices, under conditions. Great Britain and Switzerland have their own registration requirements.
United States
Rigid laryngoscopes are class I devices under 21 CFR 868.5540 (product code CCW), exempt from premarket notification subject to the limitations in the regulations, so there is usually no 510(k) clearance to show. The core of the US file is establishment registration and device listing: establishments making devices for the US market, foreign manufacturers included, register every year between 1 October and 31 December and list their devices, and a foreign establishment must name a US agent.
FDA does not issue registration certificates, so any “FDA registration certificate” was issued by a private party. Registration is not FDA approval or clearance, and US rules treat any suggestion that it is as misbranding.
Saudi Arabia
A device needs a medical device marketing authorisation (MDMA) from the Saudi Food and Drug Authority (SFDA) before it can be placed on the Saudi market. Manufacturers outside the Kingdom apply through a Saudi authorised representative. Buyers ask for the MDMA number or certificate for the exact models offered, and may ask for the representative’s or distributor’s establishment licence. Other Gulf markets have their own systems.
How to verify
A copy of a certificate is a starting point, not proof. Check each document at its source, and make sure names and addresses match across all of them; a mismatch is a reason to ask questions.
- ISO 13485: IAF CertSearch, the International Accreditation Forum’s database of accredited management-system certificates. Not every certification body uploads its data, so if a certificate is missing, check the certification body’s own register; unaccredited certificates are not listed at all.
- EU: the public EUDAMED site for the SRN, devices and certificates, and NANDO, the European Commission’s notified-body database (now in its Single Market Compliance Space), for the notified body’s number and MDR designation.
- US: FDA’s Establishment Registration and Device Listing database, for the company, address, current-year registration and listed devices.
- Saudi Arabia: the SFDA’s public list of authorised medical devices, searchable by manufacturer, brand or authorisation number, and its list of licensed establishments.
The checklist at a glance
| Document | Why buyers ask for it | How to verify |
|---|---|---|
| ISO 13485 certificate | Shows an audited quality management system | IAF CertSearch or the certification body’s register; check scope and expiry |
| EU Declaration of Conformity | The manufacturer’s legal statement of MDR conformity | Check devices, class and SRN against EUDAMED |
| Notified-body certificate, where required | Independent assessment where the class requires it | NANDO for the body; EUDAMED or the body’s own search for the certificate |
| EUDAMED actor registration (SRN) | Identifies the manufacturer and its EU representative | Public EUDAMED actor search |
| UDI | Traceability in hospital systems and EU registration | Scan the label; compare with EUDAMED device data |
| FDA establishment registration and device listing | Required to supply the US market | FDA Establishment Registration and Device Listing database |
| SFDA MDMA | Required to supply the Saudi market | SFDA list of authorised medical devices |
| IFU | Safe use, warnings and validated reprocessing | Check language and revision against devices and labels |
| Labelling samples | Confirms symbols, UDI, language and legal manufacturer | Compare with declarations, registrations and IFU |
| Test reports | Evidence behind performance and safety claims | Check laboratory, date, standard edition and samples tested |
If you are preparing a tender, send your document list to our export team.