Boer Medical (Hangzhou Boer Medical Instrument)
Tonglu, China
Tonglu manufacturer of disposable and reusable laparoscopic and gynecologic instruments and suction irrigation sets.
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Medical Instrument Companies in China
CAK Medical (Changzhou Ankang Medical Instruments)
Changzhou, China
Changzhou maker of minimally invasive surgical instruments, staplers and surgical energy devices, active since 2010.
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Changzhou Lookmed Medical Instrument
Changzhou, China
Changzhou manufacturer of disposable trocars, skin staplers, cytology brushes, polypectomy snares and other disposable devices.
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Double Medical Technology
Xiamen, China
Xiamen medical device group founded in 2004 producing orthopaedic implants and instruments plus minimally invasive, neurosurgical and dental products.
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Endosino Endoscopy (China)
Xuzhou, China
Xuzhou endoscopy company founded in 2002 manufacturing rigid endoscopes and surgical endoscopic instruments.
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Geyi Medical
China
Zhejiang manufacturer of minimally invasive surgery products, laparoscopic and gynaecology instruments and endoscopic equipment.
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Guangzhou T.K Medical Instrument
Guangzhou, China
Guangzhou developer and producer of minimally invasive consumables, surgical implants and sleep-surgery instruments.
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Hangzhou Kangya Medical Instrument
Hangzhou, China
Hangzhou producer of surgical instruments for ureteroscopy, cystoscopy, hysteroscopy, arthroscopy and laparoscopy.
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Hangzhou Sode Medical Equipment
Tonglu, China
Medical device maker in Tonglu, Hangzhou, producing laparoscopic, thoracoscopic, gynecological, ENT and urological instruments and endoscopes.
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Hangzhou Tonglu Shikonghou Medical Instrument
Tonglu, China
Tonglu manufacturer of rigid endoscopes, laparoscopic, gynecological and disposable surgical instruments, established in 2006.
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Jiangsu medical technology company founded in 2022 producing single-use electronic endoscopes, with contract manufacturing.
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Kangji Medical
Hangzhou, China
Zhejiang manufacturer of reusable and disposable instruments for laparoscopy, thoracoscopy, gynecology, urology and ENT.
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Micro-Tech (Nanjing)
Nanjing, China
Nanjing-based maker of minimally invasive devices for digestive endoscopy, interventional radiology and surgery.
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Microcure (Suzhou) Medical Technology
Suzhou, China
Suzhou maker of laparoscopic minimally invasive surgical devices founded in 2015, including insufflators, trocars, staplers and single-use retractors.
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Surgnova Healthcare Technologies
Beijing, China
Beijing surgical technology company founded in 2015 with a GMP manufacturing center for energy, stapling and endoscopy products.
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Surgsci Medical
Shenzhen, China
Shenzhen manufacturer of disposable laparoscopic instruments and surgical energy devices, founded in 2017, offering OEM and ODM services.
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Suzhou Frank Medical
Suzhou, China
Suzhou manufacturer of medical endoscope camera systems and monitors, established in 2009.
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SYA Changzhou Medical
Changzhou, China
Changzhou developer and manufacturer of medical and surgical staplers and laparoscopic devices, offering OEM service.
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Tonglu Kanger Medical Instrument
Hangzhou, China
Tonglu, Zhejiang producer of rigid endoscopes and laparoscopic, thoracoscopic, gynaecological and urological instruments, including disposable graspers.
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Tonglu Wanhe Medical Instrument (Vanhur)
Tonglu, China
Tonglu maker of laparoscopic, endoscopic, ENT, gynecology and orthopedic instruments, established in 2010.
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Tonglu Youshi Medical Instrument
Tonglu, China
Tonglu manufacturer of endoscopes and minimally invasive surgical instruments for laparoscopic, gynecological, urological, ENT and orthopedic use, founded 2005.
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TUYOU Medical
Shenzhen, China
Shenzhen manufacturer of FHD and 4K medical endoscopy camera systems with OEM and ODM services.
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Unimicro Medical Systems
Shenzhen, China
Shenzhen maker of laparoscopic trocars, retrieval pouches and suction irrigation devices, established 2011.
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Victor Medical Instruments
Changzhou, China
Changzhou maker of auto surgical staplers and minimally invasive surgery equipment.
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Business types in China
Cities in China
Medical exhibitions in China
Verified specialties 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.