Supplying hospitals on the Chinese mainland
China had more than 1.1 million healthcare institutions at the end of 2025. Yet, an imported device can be sold to none of them until it is registered or filed with the National Medical Products Administration (NMPA) and has Chinese labels. That raises two questions first. Has the maker's agent in China taken the model through NMPA, and which port will it clear through? The rules below apply to the mainland only.
We're MediGear, a medical equipment distributor registered in England and Wales, and we support healthcare buyers in more than 80 countries with quotes, documents, and freight. Tell us the model or the clinical need. Verified makers who can supply it come first, then we check the points a mainland import will raise, and we write the quote for your clinical and buying staff. Requests start on our buyers page, with no account needed.
Public, military and private buyers on the mainland
On the mainland, our quotes go to buyers such as:
- Public and teaching hospitals such as Peking Union Medical College Hospital and West China Hospital of Sichuan University
- University hospitals such as the First Affiliated Hospital of Zhejiang University School of Medicine in Hangzhou
- Military hospitals, including the PLA General Hospital
- Specialist dental institutions, including private chains and dental clinics
- Private hospital groups such as United Family Healthcare in Beijing, Shanghai and Guangzhou
- Hospitals planning molecular imaging with PET/CT or PET/MR, both on the list of large equipment that needs a configuration licence
- Distributors selling medical devices in China, which need a filing for Class II devices and a licence for Class III
Purchasing routes vary widely. A public hospital adding a department buys through state tenders, with notices on the Ministry of Finance's China Government Procurement Network and a review step before foreign goods can be chosen. A private dental chain that needs one new panoramic unit wants a quick, clear quote and an agent who has the paperwork in hand. We ask which route applies before we start, because it shapes the whole quote.
NMPA registration through an agent in China
The rules are set out in State Council Decree No. 739 on the oversight of medical devices, in force since June 2021. An imported Class I device is filed with NMPA, and an imported Class II or III device is registered, each in China through a company the overseas manufacturer appoints as its agent. NMPA's registration and filing provisions make the maker the holder, with the agent in support, and a certificate lasts five years.
Imported devices must carry Chinese instructions and Chinese labels, and the instructions must name the origin and the agent, or the devices may not be imported. No dealer in China's medical device distribution system may sell a device that is not registered or filed, and no hospital may use one. Customs checks imported devices before release. If no entry covers your model, the maker's agent would have to get one first. We are not an NMPA agent or registrant and cannot give regulatory advice. The quote lists every certificate the unit holds, for your team to check.
Two X-ray licences for Chinese diagnostic imaging departments
In China, medical X-ray equipment is regulated from two directions. Any unit that makes, sells or uses X-ray devices must hold a radiation safety licence, issued by the Ministry of Ecology and Environment for selling or using Class I devices and by the provincial ecology and environment department for the rest, as the ministry's licensing measures set out, and the licence lasts five years. A new classification of radiation-emitting devices, published by the ministry and the National Health Commission, took effect in October 2026.
Hospitals also need a licence from the health authorities for radiation diagnosis and treatment issued at the county level for X-ray imaging. A radiation protection review comes before building work, and a check on its effect comes before the building is signed off. New, repaired or major-part-replaced equipment must pass a test by a certified body before use, with a status test at least once a year. Talk to both while the quote is still open, and ask us for the technical data they need.
What we settle with the manufacturer for China
A precise specification makes for a reliable quote, especially for high-end medical devices. For mainland sites, we usually settle these points with the manufacturer:
- Sockets and supply. Mainland sockets accept Type C and Type I plugs, among others. Confirm the supply rating with your engineering department, because a unit built for 110 V or 60 Hz may need a different factory build.
- Tests and records. Users must check, test, calibrate and maintain devices as the instructions require, and keep records. Ask for the service manual and test data early so that the formal test can be booked.
- Wear parts. Electrodes on cardiology equipment, ultrasound probes, and cartridges wear out, so the maker's supply period matters. We confirm what fits, and list the spare parts and consumables available to reorder.
- Chinese software. Check the interface language, the DICOM and HL7 options on diagnostic imaging systems and other medical diagnostic equipment, and anything your IT team needs before the unit joins the network.
Should anything be unclear, the manufacturer hears from us before we quote. Settling a detail now avoids a long wait once the unit is at the port.
Customs file and crate checks for the mainland
Customs checks imported devices against their registration, so every order leaves with a full file:
- Commercial invoice and detailed packing list
- Certificate of origin for the declaration
- HS codes for every line
- A copy of the NMPA registration certificate or filing record
- Chinese labels and instructions naming the origin and the agent
Wooden crates are checked as well. China has told the International Plant Protection Convention that it applies ISPM 15 to imported wood packaging. Customs is responsible for the quarantine checks at entry on plants and plant products. We request treated, clearly marked crates from the start, because goods that fail a port inspection can be treated, re-exported, or destroyed.
Ordering, then shipping to the mainland
- Give us the brief. Include the model, specification, quantity, hospital and the manufacturer's agent in the RFQ form or an email.
- Weigh up the quote. Usually within 48 hours for catalogue items, it gives the product, lead time, certification and route. Compare it with any quotes you hold from healthcare equipment suppliers.
- Give your written go-ahead. Only then does the quote become an order.
- The route to China. Sea freight into Shanghai or Tianjin, or air freight through Guangzhou Baiyun, Shanghai Pudong or Beijing for smaller or urgent items.
The quote runs to the port or airport you nominate, such as Shanghai or Beijing Capital. From there, the consignee declares the goods themselves or through a customs broker they appoint, as Shanghai's guide to customs registration explains, and you arrange the last leg to site. Typhoons hit Guangdong, Hainan, Fujian and Zhejiang most often in summer and autumn, so tell us early if a south coast port is in the plan.
Why mainland quotes are for new units
A private clinic that needs one monitor can order just that, because most catalogue lines are quoted per unit. We also quote multi-line requests for new departments and private hospital projects; see private tender for that work. Endoscopy teams can browse Gastroenterology Equipment, and hospital labs and lab equipment suppliers can send us a brief. Our refurbished range cannot serve the mainland. Decree 739 bans importing used devices, and the national catalogue of second-hand products barred from import lists used medical instruments and X-ray and CT units. Every quote is therefore for a new unit, even when you ask about refurbished equipment in China.
Disclaimer
This page is general information for buyers on the Chinese mainland. Nothing on it is an offer to supply, and it should not be relied on as legal, regulatory or customs advice. Quotes depend on what makers can supply, and no order is firm until both sides agree in writing. An imported device can be supplied only once it is registered or filed with NMPA and labelled in Chinese. X-ray equipment also requires a radiation safety licence and a radiological licence. Used devices may not be imported. Customs clearance and the regulatory status of your purchase are your responsibility. We do not act as an NMPA agent or registrant.
Buying medical devices in China?
Which mainland port is the unit heading for? Send that with the model number, a data sheet or a photo of the current unit, and we'll reply with a quote for a new unit that sets out its NMPA status, the Chinese labelling and the route.
Frequently Asked Questions
Neither an account nor a registration is needed. A model number or specification sent to connect@medigear.uk, or through the RFQ form on the buyer's page, is all we need to start. We quote for public and teaching hospitals, military hospitals, private groups, dental institutions and licensed medical device distributors, and every quotation arrives by email.
Yes. Imported Class I devices are filed with NMPA, and Class II and III devices are registered through an agent in China appointed by the manufacturer. Devices without registration or filing may not be imported or used, and suppliers in China may not sell them. Check the status before you place an order.
The manufacturer's agent would have to register or file it with NMPA first. There is a narrow route for a medical institution to import a small quantity for urgent clinical need with approval, but it is limited to designated institutions. We can usually suggest a comparable model that is already registered.
Two: a radiation safety licence from the ecology and environment authorities, and a radiological diagnosis and treatment licence from the health authorities. New X-ray systems, CT included, must also pass a test by a certified body before use. Start both applications while the quotation is still open.
Sea freight can go into Shanghai or Tianjin, and air freight can go through Guangzhou Baiyun, Shanghai Pudong or Beijing. Delivery is to the point you nominate, and customs clearance and the onward journey to your hospital are your responsibility.
The consignee does, either directly or through a customs broker it appoints, using the China International Trade Single Window. We provide the commercial invoice, packing list, certificate of origin, HS codes, and a copy of the NMPA registration; the labels must already be in Chinese.
Yes. A single unit can be quoted on most catalogue lines, from a monitor to laboratory testing equipment, and we raise any manufacturer minimum order quantity straight away. Let us know about the final leg as well, such as a long road haul inland, and we will ask for packing to suit.
Manufacturer stock, the registration position, the shipping point and the choice of sea or air all affect them. We cannot ship refurbished medical devices to the mainland, as used devices may not be importable, so lead times apply to new stock. The quote states the lead time and the route, and email updates keep you posted until arrival.