Buying medical equipment from China: standards, CB reports, installation and service

This guide covers electrical hospital equipment: patient monitors, infusion and syringe pumps, diagnostic ultrasound, X-ray, critical care ventilators, medical beds and operating tables. Sinospect checked the standard editions and the rules below at the issuing bodies on 26 September 2026.

The IEC 60601 family: three levels of standard

Electrical medical equipment is tested against three levels of standard that apply together. The general standard, IEC 60601-1, sets basic safety and essential performance for all medical electrical equipment. Collateral standards add requirements shared across equipment types, such as electromagnetic compatibility or alarm systems. A particular standard for each equipment type modifies and adds to the general standard, and its requirements take precedence where the two differ.

The general standard in force is the 2005 edition with its amendments of 2012 and 2020. The IEC webstore also lists “IEC 60601-1:2026 SER”, published in July 2026. It is a pack of all the parts, and the general standard inside it is the same edition.

Particular standards by equipment type

Four of these seven standards got a new edition between 2022 and 2024, and a fifth an amendment in 2024, so the edition on the test report is the first thing to check.

The CB test report: the document to request

Under the IECEE CB Scheme, a CB testing laboratory tests the equipment against the IEC standards, and a national certification body issues a CB test certificate on the report. The report follows a test report form that IECEE publishes for each standard and edition, so it states exactly which editions and amendments the equipment was tested to, and it lists the national differences tested for the destination country.

Every CB test certificate issued by an IECEE member appears in the IECEE online database, where anyone can search the public extract by certificate number or holder. Check that the holder and the factory locations match the manufacturer’s other records, and that the models on the quote are among the models tested.

The regulatory frame, market by market

European Union. Under the MDR, active devices are classified by Annex VIII, Rules 9 to 13. Diagnostic and monitoring equipment is Class IIa, and Class IIb when it monitors vital physiological parameters whose variations could put the patient in immediate danger, or emits ionizing radiation for diagnostic radiology (Rule 10). Equipment that administers medicines or body liquids is Class IIa, or IIb when the administration is potentially hazardous (Rule 12). Other active devices, such as powered beds and operating tables, are Class I (Rule 13). Every class from IIa up needs a notified body certificate, recorded in EUDAMED.

United States. The FDA product classification database gives each device’s class and route; most hospital equipment in these families needs 510(k) clearance, and the manufacturer’s establishment registers and lists the device.

China. Class II and III equipment is registered with the NMPA or a provincial administration. The licences, the registration numbers and the export certificates are explained in how to verify a Chinese medical device manufacturer.

EU public tenders: the procurement measure on Chinese medical devices

Commission Implementing Regulation (EU) 2025/1197, adopted on 19 June 2025 and in force since 30 June 2025, excludes tenders from economic operators originating in China from EU public procurement of medical devices (CPV codes 33100000-1 to 33199000-1) with an estimated value of EUR 5 million or more, net of VAT. Contracting authorities determine the origin of both the tenderers and the devices.

In those procedures, the successful tenderer may subcontract at most 50% of the contract value to Chinese operators and, in a supply contract, may deliver goods of Chinese origin up to 50% of the contract value, with evidence on request; a breach carries a charge of 10% to 30% of the contract value (Regulation (EU) 2022/1031, Article 8). The measure expires five years after its entry into force and may be extended for five years.

Tenders below EUR 5 million, private purchases and markets outside the EU fall outside the measure.

Connected equipment and cybersecurity

On 30 January 2025 the FDA reported three cybersecurity vulnerabilities in Contec CMS8000 patient monitors, also sold relabelled as Epsimed MN-120: remote control by an unauthorised user, a backdoor in the software, and transmission of patient data outside the care environment once the monitor is online. At the time, the FDA stated that no software patch was available and advised disconnecting the monitors from networks and using only their local monitoring features.

For connected equipment, ask for the software version, the security documentation and the patch policy, and identify the manufacturer behind the brand. IEC 62304:2006 with Amd 1:2015 sets the software life cycle, and IEC 81001-5-1:2021 the security activities within it; risk management follows ISO 14971:2019 and usability engineering IEC 62366-1:2015 with Amd 1:2020.

Installation, acceptance and service: what the offer must state

WHO’s health technology management guidance treats installation, maintenance and training as part of equipment management, and its technical specifications for medical devices are written for tendering and maintenance planning. An offer ready to compare states:

• the site requirements: power, space, environment and, for X-ray, the shielding plan the destination’s radiation authority requires;
• installation and commissioning, with the acceptance test at site and its record;
• user and technical training, the service manual and the tools it calls for;
• the spare parts list with prices, lead times and the years of supply;
• preventive maintenance, calibration, software updates and security patches;
• the warranty period, exclusions, response times and the local service provider.

For complex systems, a factory acceptance test before shipment is one step in that sequence.

Buyer checklist

Before the order

• The particular standard and its edition for the equipment type, the general and collateral standards, and the CB test certificate with its full report naming those editions.
• The CB certificate found in the IECEE database, with the holder, factory and models matching the offer.
• The manufacturer’s records, checked as in how to verify a Chinese medical device manufacturer, including the maker behind any brand.
• The destination approval: the MDR class and notified body certificate in EUDAMED, the FDA listing and clearance, or the destination’s own registration.
• For connected equipment: the software version, the security documentation and the patch policy.
• For an EU public tender of EUR 5 million or more: the origin rules of the procurement measure.
• The service terms in writing: installation, acceptance at site, training, service manual, spare parts, maintenance, warranty and local service.

Before shipment

• Serial numbers, software versions and accessories checked against the order and the CB report.
• Labels, instructions for use and the service manual in the destination language.

Frequently asked questions

Sources

Checked at the issuing bodies on 26 September 2026.

• IEC and ISO: IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1:2026 SER (series pack), IEC 60601-1-2:2014+A1:2020, IEC 60601-1-8:2006+A1+A2, IEC 60601-1-6:2010+A1+A2, IEC 80601-2-49:2018+A1:2024, IEC 60601-2-24:2012, IEC 60601-2-37:2024, IEC 60601-2-54:2022, ISO 80601-2-12:2023, IEC 60601-2-52:2009+A1:2015, IEC 80601-2-89:2025, IEC 60601-2-46:2023, IEC 62304:2006+A1:2015, IEC 62366-1:2015+A1:2020, IEC 81001-5-1:2021, ISO 14971:2019
• IECEE: CB Scheme, CB test certificate database
• European Union: Regulation (EU) 2017/745, Annex VIII, Implementing Regulation (EU) 2025/1197, Regulation (EU) 2022/1031
• FDA and CISA: Contec and Epsimed patient monitors, safety communication, CISA: Contec CMS8000 contains a backdoor, product classification database
• WHO: procurement process resource guide, technical specifications for medical devices