ISO 13485, CE and market authorisations in four countries
Keling manufactures under an SGS-certified ISO 13485 quality system whose scope explicitly includes hospital beds, CE marks its products for the European market, and holds registrations or marketing authorisations for the United States, Saudi Arabia, Ethiopia and Uzbekistan. The company is also approved to ISO 9001 and has been awarded National Hi-Tech Enterprise status.
Which certifications and market authorisations does Keling hold?
Keling Medical hospital beds are CE marked and manufactured under ISO 9001 and ISO 13485. The ISO 13485:2016 certificate is issued by SGS United Kingdom Ltd (CN18/42037) and its certified scope covers the design and manufacture of hospital beds. Beyond Europe, Keling holds a US FDA establishment registration and medical device authorisations from the Saudi Food & Drug Authority, the Ethiopian Food and Drug Authority and the Ministry of Health of Uzbekistan. Current signed certificates are issued with every quotation; the scans below let buyers verify scope and registration details before requesting the originals.
The six documents
Every certificate is shown whole. Press any one to read it at full size.
What each document actually covers
Certificates are easy to show and hard to read. Here is what each of these is, in plain terms.
ISO 13485:2016 · EN ISO 13485:2016
SGS United Kingdom Ltd — certificate CN18/42037
Quality management for medical devices. The certified scope covers the design and manufacture of operating tables, operating lamps, suction machines, ceiling pendants, X-ray film viewers, wheelchairs and hospital beds.
EU Declaration of Conformity (CE)
Jiangsu Keling Medical Appliances Co., Ltd., with an EU authorised representative
The manufacturer's declaration that the products meet the applicable European requirements, which is what allows them to be placed on the EU/EEA market.
US FDA establishment registration
US Food and Drug Administration — certification of registration
Registration of the manufacturing establishment with the FDA. This is a registration of the site, not an FDA approval or clearance of an individual device.
Saudi Arabia — medical device marketing authorisation
Saudi Food & Drug Authority (SFDA)
Authorisation to market medical devices in the Kingdom of Saudi Arabia — the document Gulf project buyers and their consultants normally ask for first.
Ethiopia — product market authorisation
Ethiopian Food and Drug Authority (EFDA)
Market authorisation for Keling products in Ethiopia, listing the authorised models.
Uzbekistan — registration certificate
State Centre for Expertise and Standardisation of Medicines, Medical Devices and Medical Equipment, Ministry of Health of the Republic of Uzbekistan
Registration of Keling medical equipment for the Uzbek market. Ask us for the current certificate if you need the exact registered model list.
What each standard means for an importer
- CE marking
- A declaration that the product meets the applicable European health, safety and environmental requirements. For a hospital bed this is what allows the device to be placed on the market in the EU/EEA, and is frequently required by tenders outside Europe as a proxy for third-party scrutiny.
- ISO 13485
- The quality management system standard written specifically for medical devices. It covers design control, traceability of materials and components, validation of production processes such as welding and coating, complaint handling and post-market surveillance. It is audited by an external certification body.
- ISO 9001
- The general quality management standard, covering process control, corrective action and continual improvement across the whole business rather than just the device file.
- National Hi-Tech Enterprise
- A Chinese government designation requiring a sustained level of in-house R&D spending, technical staff ratio and owned intellectual property. Keling's provincial enterprise technology centre supports this status.
Using our certificates in your tender
- Signed, dated copies — we issue current PDFs with the quotation rather than asking you to work from a website scan.
- Declaration of Conformity per model, referencing the applicable directive and standards.
- Test reports and datasheets for the specific model and configuration you are bidding.
- Certificate of Origin, packing list and commercial invoice prepared by the Shanghai export office.
- Factory audit — third-party inspection and customer audits are welcome at the Yangzhou plant.
Bidding a tender with a compliance annex?
Send us the annex. We will map each clause to the model, the standard and the document that evidences it, so your submission is complete the first time.