66 Vision Tech
Suzhou, China
Suzhou ophthalmic device maker producing microsurgical instruments, surgical microscopes and slit lamps; a Yuwell subsidiary since 2020.
AHANVOS (Beijing Jinhengwei)
Beijing, China
Beijing manufacturer of electrosurgical generators and bipolar and monopolar accessories under the AHANVOS brand, founded 2000.
AK Medical
Beijing, China
Beijing orthopedic group founded in 2003 that develops and manufactures artificial joints and orthopedic implants.
Alton (Shanghai) Medical Instruments
Shanghai, China
Shanghai manufacturer of endoscopic accessories for GI, respiratory and urological procedures and single-use endoscopes.
AOYE Medical (Aoyujian Medical Technology)
Changzhou, China
Changzhou orthopedic implant manufacturer for trauma, spine and sports medicine, offering OEM with low MOQ.
Beijing Fule Science & Technology Development
Beijing, China
Beijing orthopaedic implant manufacturer founded in 1996, producing spine and trauma products and exporting abroad.
Beijing Greenland
Beijing, China
Beijing manufacturer of electrosurgical units and RF and plasma systems, established in 2003, exporting to over 30 countries.
Beijing Lidakang Technology
Beijing, China
Beijing company founded in 1998 that researches, develops and produces artificial joint implants.
Benzgum Medical Technology (Surgica Supply)
Hangzhou, China
Hangzhou company supplying electrosurgical pencils, electrodes and tungsten needles under the Surgica Supply name.
Boer Medical (Hangzhou Boer Medical Instrument)
Tonglu, China
Tonglu manufacturer of disposable and reusable laparoscopic and gynecologic instruments and suction irrigation sets.
CAK Medical (Changzhou Ankang Medical Instruments)
Changzhou, China
Changzhou maker of minimally invasive surgical instruments, staplers and surgical energy devices, active since 2010.
CareOrtho
Zhangjiagang, China
Manufacturer of veterinary orthopedic implants and instruments, offering OEM/ODM and handling export documentation.
Cathay Manufacturing Corp
Shanghai, China
Shanghai manufacturer of electrosurgical pencils, grounding pads, TENS and ECG electrodes, established in 2011.
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.
Chongqing Xishan Science & Technology (Xishan Medical)
Chongqing, China
Chongqing manufacturer of surgical power tools and endoscopy systems since 1999.
COXO Medical
Foshan, China
Foshan dental device maker established in 2003, producing handpieces, implant and surgery motors, endodontic devices and air polishers.
Denrotary Medical
Ningbo, China
Ningbo orthodontic products maker with bracket production lines, producing elastics and self-ligating brackets.
Double Medical Technology
Xiamen, China
Xiamen medical device group founded in 2004 producing orthopaedic implants and instruments plus minimally invasive, neurosurgical and dental products.
Endosino Endoscopy (China)
Xuzhou, China
Xuzhou endoscopy company founded in 2002 manufacturing rigid endoscopes and surgical endoscopic instruments.
Foshan Senda Medical Instrument
Foshan, China
Foshan company established in 2014 producing high- and low-speed dental handpieces and supplying dental burs.
Foshan Vimel Dental Equipment
Foshan, China
Foshan maker of dental air turbine handpieces and dental equipment, established in July 2015.
Foshan Wenjian Medical
Foshan, China
Foshan producer of dental high- and low-speed handpieces and endomotors, established in 2010, with OEM/ODM service.
Business types in China
Cities in China
Medical exhibitions in China
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.