Import & export
Importing hospital equipment from China: documents, shipping and inspection
A practical guide for distributors and hospitals importing medical equipment from China. Which certificates to ask for, how to read Incoterms, packing, inspection and registration.
Buying hospital equipment directly from the factory can cut cost and give you control over specifications, but it also moves work onto the importer: checking certificates, agreeing terms, arranging inspection and clearing customs. This guide walks through each stage as a checklist.
1. Verify the manufacturer
Ask for, and check, these documents before you negotiate price:
- ISO 13485 certificate for the quality management system, issued by a recognised certification body. You can usually verify the certificate number on the issuer's website. Keling's is certificate CN18/42037, issued by SGS to Jiangsu Keling Medical Appliances Co., Ltd., covering design and manufacture of operation tables, operation lamps, suction machines, ceiling pendants, X-ray film viewers, wheelchairs and hospital beds.
- Business licence showing the legal manufacturer.
- Factory photos or a visit - in person, by video, or through an inspection company.
2. Check the regulatory route for your country
Each market has its own rules. Common examples:
| Market | What to ask for |
|---|---|
| European Union | CE marking under Regulation (EU) 2017/745 (MDR), EU Declaration of Conformity, EU authorised representative |
| United States | FDA establishment registration and device listing, plus 510(k) clearance where the device class requires it |
| Saudi Arabia | SFDA Medical Device Marketing Authorization (MDMA) |
| Ethiopia | EFDA product market authorization |
| Uzbekistan | State registration certificate |
Keling holds documents in each of the markets above; see the About page. Always confirm with your own regulator which documents apply to your device class.
3. Agree the specification in writing
For each model, confirm:
- voltage, frequency and plug type
- gas outlet standard for pendants
- colour, labelling and language of manuals and labels
- accessories included and optional
- OEM branding, if any
A signed proforma invoice with these details is your reference for inspection.
4. Understand Incoterms
Incoterms 2020 define who arranges and pays for each part of the journey, and where risk passes:
- EXW (Ex Works): you collect from the factory and handle everything.
- FOB (Free On Board): the seller delivers the goods on board at the Chinese port, typically Shanghai. You arrange sea freight and insurance.
- CIF (Cost, Insurance and Freight): the seller pays freight and insurance to your port; risk passes when goods are on board in China.
- DAP / DDP: the seller delivers to your named place, without or with import duties paid.
5. Packing and loading
Hospital equipment is bulky. Ask for:
- carton or crate dimensions and gross weights per item, to plan container loading
- export-grade packing: plywood crates (ISPM 15 treated) for heavy items such as operating tables
- a packing list with model numbers and serial numbers
6. Inspection
Many importers book a third-party pre-shipment inspection. The inspector checks quantities, finishes, functions and packing against the proforma invoice and photographs each item. Book it a few days before the cargo-ready date.
7. Shipping documents and customs
Typical documents are the commercial invoice, packing list, bill of lading or airway bill, certificate of origin and copies of product certificates. Medical furniture such as operating tables, examination tables and hospital beds with mechanical fittings is classified under HS heading 9402; ask your customs broker to confirm the full national code and duty rate.
8. After delivery
Plan installation, staff training and spare parts before goods arrive. Keep manuals, datasheets and certificates on file for your regulator and for tenders.
Have a tender or project list? Send it to the export team and ask for a consolidated quotation with packing details.
Frequently asked questions
What certificates should a Chinese medical equipment manufacturer have?
At minimum, an ISO 13485 quality management certificate from a recognised certification body. For Europe, a CE marking under the EU MDR with a Declaration of Conformity; for the US, FDA establishment registration and the applicable product clearance; for Saudi Arabia, SFDA marketing authorization. Requirements vary by country and device class.
What Incoterm should I use when buying from China?
FOB (Free On Board) is the most common for experienced importers who have their own forwarder. CIF suits buyers who want the seller to arrange sea freight. EXW puts every step on the buyer, and DAP or DDP put more on the seller.
How long does it take to import hospital equipment from China?
It depends on production time for built-to-order items, the shipping route and customs clearance at destination. Ask the supplier for a production lead time per item and your forwarder for transit times.
