AOYE Medical (Aoyujian Medical Technology)
Changzhou, China
Changzhou orthopedic implant manufacturer for trauma, spine and sports medicine, offering OEM with low MOQ.
CAK Medical (Changzhou Ankang Medical Instruments)
Changzhou, China
Changzhou maker of minimally invasive surgical instruments, staplers and surgical energy devices, active since 2010.
Changzhou Dingjian Medical
Changzhou, China
Changzhou developer and manufacturer of orthopedic implants and instruments for trauma, spine, joints and sports medicine.
Changzhou Geasure Medical
Changzhou, China
Changzhou orthopaedic device company that researches, manufactures and sells trauma and spine implants and associated surgical instruments.
Changzhou Lookmed Medical Instrument
Changzhou, China
Changzhou manufacturer of disposable trocars, skin staplers, cytology brushes, polypectomy snares and other disposable devices.
Jiangsu ATE Medical Technology
Changzhou, China
Wujin, Changzhou manufacturer of disposable biopsy forceps, injection needles and other endoscopic accessories.
Lyntop Medical
Changzhou, China
Changzhou orthopedic implant and instrument company operating an ISO 13485 certified factory.
SYA Changzhou Medical
Changzhou, China
Changzhou developer and manufacturer of medical and surgical staplers and laparoscopic devices, offering OEM service.
Trauhui Medical
Changzhou, China
Changzhou orthopedic implant and instrument manufacturer founded in 2009, exporting to 30+ countries.
Victor Medical Instruments
Changzhou, China
Changzhou maker of auto surgical staplers and minimally invasive surgery equipment.
Business types in Changzhou
Regulation in China
China's device law (Order 739, in force 1 June 2021) uses Classes I–III: Class I filing, Class II/III registration, plus production and distribution licensing.
From the sourced NMPA / Order 739 entry, checked 29 October 2026. General information, not legal advice. Requirements for China · All medical certifications
Frequently asked questions
Does a foreign manufacturer need a China agent to sell devices in China?
Yes. Under Order No. 739, overseas registrants (Class II and III) and filers (Class I) must designate an enterprise legal person in China to submit the registration or filing to NMPA. The agent also helps with post-market duties: quality management, adverse event monitoring, re-evaluation, traceability and recalls. The Chinese IFU must name the country of origin and the designated Chinese enterprise.
The agent is distinct from importers and distributors, which need their own business filing (Class II) or license (Class III). Imported devices also need proof that they may be marketed in the country or region of origin. See the medical certifications page.
How does China’s NMPA regulate medical devices?
China regulates devices under State Council Order No. 739 (in force since 1 June 2021), with three classes set mainly through NMPA's Medical Device Classification Catalog:
- Class I: product filing (domestic makers with the city-level regulator; imported devices with NMPA).
- Class II and III: product registration, with technical requirements, type testing and clinical evaluation unless exempt. Certificates are valid for five years.
- Overseas makers must appoint an enterprise legal person in China as their agent.
- Imported devices need Chinese-language labels and instructions for use.
Domestic manufacturing and distribution also need filings or licenses by class. English translations of the rules are unofficial. See the medical certifications page.
How long is a Chinese medical device registration certificate valid?
Five years. Article 22 of Order No. 739 sets a five-year validity for Class II and III registration certificates, and the registrant must apply for renewal at least six months before expiry. Production licenses and Class III business licenses are also valid for five years.
When a Chinese supplier quotes a registration number, ask for a copy of the certificate and check the registrant's name, the product name and models, and the expiry date. The certificate covers the Chinese market only. Listed Chinese companies are spread across cities such as Changzhou, Beijing and Hangzhou; see the China country page.
Which Chinese licenses should an instrument factory in China hold?
For devices sold in China, a domestic manufacturer needs product authorization and a manufacturing authorization matched to the class:
- Class I: product filing plus production filing with the municipal authority;
- Class II and III: a product registration certificate plus a provincial production license. Both are valid for five years.
Distributors need a Class II business filing or a Class III business license. These authorizations cover the Chinese market. If you are importing from a Chinese factory into the EU, US or elsewhere, ask separately for the destination-market evidence (for example CE marking with a notified body certificate, or FDA registration and listing). The directory currently lists more than 70 companies in China; see the China country page.