Chongqing Xishan Science & Technology (Xishan Medical)
Chongqing, China
Chongqing manufacturer of surgical power tools and endoscopy systems since 1999.
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Medical Instrument Companies in China
Endosino Endoscopy (China)
Xuzhou, China
Xuzhou endoscopy company founded in 2002 manufacturing rigid endoscopes and surgical endoscopic instruments.
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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 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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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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Kangji Medical
Hangzhou, China
Zhejiang manufacturer of reusable and disposable instruments for laparoscopy, thoracoscopy, gynecology, urology and ENT.
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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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Zhejiang Jiacheng Medical Instrument
Tonglu, China
Tonglu endoscope manufacturer offering rigid ENT endoscopes, arthroscopes and repair services, established in 2022.
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Zhejiang Tiansong Medical Instrument
Tonglu, China
Tonglu company producing rigid medical endoscopes, minimally invasive surgical instruments and disposable instruments.
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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.