AK Medical
Beijing, China
Beijing orthopedic group founded in 2003 that develops and manufactures artificial joints and orthopedic implants.
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Medical Instrument Companies in China
AOYE Medical (Aoyujian Medical Technology)
Changzhou, China
Changzhou orthopedic implant manufacturer for trauma, spine and sports medicine, offering OEM with low MOQ.
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Beijing Fule Science & Technology Development
Beijing, China
Beijing orthopaedic implant manufacturer founded in 1996, producing spine and trauma products and exporting abroad.
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Beijing Lidakang Technology
Beijing, China
Beijing company founded in 1998 that researches, develops and produces artificial joint implants.
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CareOrtho
Zhangjiagang, China
Manufacturer of veterinary orthopedic implants and instruments, offering OEM/ODM and handling export documentation.
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Changzhou Dingjian Medical
Changzhou, China
Changzhou developer and manufacturer of orthopedic implants and instruments for trauma, spine, joints and sports medicine.
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Changzhou Geasure Medical
Changzhou, China
Changzhou orthopaedic device company that researches, manufactures and sells trauma and spine implants and associated surgical instruments.
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Chongqing Xishan Science & Technology (Xishan Medical)
Chongqing, China
Chongqing manufacturer of surgical power tools and endoscopy systems since 1999.
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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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Grandtek Medical
China
Chinese orthopedic power tool and instrument maker serving hospitals and distributors internationally.
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Fourth-generation family business in Sialkot making surgical and dental instruments since 1974, with 15,000+ products in 14 disciplines sold in 50+ countries.
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Jiangsu Jinlu Group Medical Device
Zhangjiagang, China
Zhangjiagang manufacturer of orthopaedic implants and instruments established in 1958, exporting to more than 50 countries.
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Jiangsu Shuangyang Medical
Zhangjiagang, China
Jiangsu orthopedic implant R&D and manufacturing company founded in 2001 for trauma, spine and maxillofacial systems.
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Just Medical Devices (Tianjin)
Tianjin, China
Tianjin manufacturer of hip and knee implants and instruments, established in 1958.
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Lyntop Medical
Changzhou, China
Changzhou orthopedic implant and instrument company operating an ISO 13485 certified factory.
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Ningbo Five Continents Medical
Yuyao, China
Yuyao maker of disposable pulse lavage systems, PEEK and titanium suture anchors and arthroscopy shaver blades.
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Shandong Weigao Orthopaedic (WEGO Ortho)
Weihai, China
Weihai producer of spine, trauma, joint and sports medicine implants, bone repair materials and orthopedic instruments.
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Shanghai Future Orthopedic Instrument (FOI)
Shanghai, China
Orthopedic equipment manufacturer established in 1996 producing medical power drills and saws, with a Shanghai office.
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Shanghai Kinetic Medical
Shanghai, China
Shanghai orthopedic medical device company founded in 2005, developing and producing spine, sports medicine, trauma and biomaterial products.
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Spine-Inno (Tianjin Lingchuang Yihui Medical Technology)
Tianjin, China
Tianjin company established in 2018 providing endoscopic minimally invasive spinal surgery instruments and OEM production.
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Suzhou Youbetter Medical
Zhangjiagang, China
Zhangjiagang orthopedic implant producer with over 20 years of production experience and OEM business.
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Tianjin Fuxiang Medical Tech
Tianjin, China
Tianjin orthopedic manufacturer founded in 2001 producing trauma, spinal and joint replacement implants, with OEM supply.
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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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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.