Beijing Fule Science & Technology Development
Beijing, China
Beijing orthopaedic implant manufacturer founded in 1996, producing spine and trauma products and exporting abroad.
Chongqing Xishan Science & Technology (Xishan Medical)
Chongqing, China
Chongqing manufacturer of surgical power tools and endoscopy systems since 1999.
Frimen
Huai'an, China
Huai'an maker of ophthalmic surgical instruments, eye instruments and disposable instruments, producing to OEM samples.
Geyi Medical
China
Zhejiang manufacturer of minimally invasive surgery products, laparoscopic and gynaecology instruments and endoscopic equipment.
Grandtek Medical
China
Chinese orthopedic power tool and instrument maker serving hospitals and distributors internationally.
Jiangsu Shuangyang Medical
Zhangjiagang, China
Jiangsu orthopedic implant R&D and manufacturing company founded in 2001 for trauma, spine and maxillofacial systems.
Nanjing Redsun Optical
Nanjing, China
Nanjing manufacturer and distributor of optical lenses and ophthalmic instruments.
Shandong Weigao Orthopaedic (WEGO Ortho)
Weihai, China
Weihai producer of spine, trauma, joint and sports medicine implants, bone repair materials and orthopedic instruments.
Suzhou Frank Medical
Suzhou, China
Suzhou manufacturer of medical endoscope camera systems and monitors, established in 2009.
TAKTVOLL (Beijing Taktvoll Technology)
Beijing, China
Beijing electrosurgical technology manufacturer founded in 2013 producing generators, pencils and related surgical solutions.
VetMED Tech
Beijing, China
Beijing veterinary equipment manufacturer since 2012 producing ultrasonic scalpels and anesthesia machines.
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.