Updated 22 October 2026
In-vitro diagnostics distributors in China: 546 licensed establishments
The Bastion Hale Distributor Index lists 546 establishments in China whose registry records include in-vitro diagnostics: 17 with a channel role (importer, distributor, wholesaler or authorised representative), 48 registration holders without a channel role, and 481 registered as manufacturer or exporter only, out of 5,150 medical device establishments in China overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 17 | 3% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 51 | 9% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 519 | 95% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 217 | 40% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in China
In China the NMPA registration certificate is issued in the overseas manufacturer's name, but a legal agent based in China is mandatory and import goes through licensed operators holding a medical device business licence. The agent appointment, not the distribution agreement, controls the registration.
Top 20 in-vitro diagnostics establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD. Shijiazhuang Hebei | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +8 more | 117 | 1 | 0 | 41.0 | 3/5 |
| 2 | SHENZHEN YUWEN E-COMMERCE CO., LTD. Shenzhen Guangdong, Guangdong | Channel Distributor, Manufacturer, Exporter | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology +2 more | 23 | 2 | 0 | 38.2 | 3/5 |
| 3 | BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD. Beijing City | Channel Distributor, Registration holder, Manufacturer, Exporter | In-vitro diagnostics, Patient monitoring and neurology | 6 | 7 | 0 | 37.8 | 3/5 |
| 4 | DIRUI INDUSTRIAL CO., LTD. CHANGCHUN Jilin | Channel Distributor, Manufacturer | General hospital and consumables, In-vitro diagnostics | 84 | 1 | 0 | 37.7 | 3/5 |
| 5 | SAFERLIFE PRODUCTS CO.,LTD. Guangzhou Guangdong | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 60 | 1 | 0 | 37.6 | 3/5 |
| 6 | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. BEIJING | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 59 | 1 | 0 | 37.5 | 3/5 |
| 7 | WENZHOU CARETEK MEDICAL DEVICE CO., LTD Wenzhou Zhejiang | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 45 | 1 | 0 | 36.2 | 3/5 |
| 8 | GAUKE (HUBEI) HEALTHCARE CO., LTD Huanggang City Hubei | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 34 | 1 | 0 | 34.8 | 3/5 |
| 9 | WUXI LYUSMILE IMP AND EXP CO.,LTD WUXI Jiangsu | Channel Distributor | General hospital and consumables, Dental, In-vitro diagnostics +3 more | 66 | 1 | 0 | 34.2 | 3/5 |
| 10 | BIOMED PLASTICS CO. TAICANG, JIANGSU | Channel Distributor, Manufacturer | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +3 more | 29 | 1 | 0 | 32.4 | 3/5 |
| 11 | BEIJING HONGDEE CORPORATION Beijing | Channel Distributor | Cardiovascular, General hospital and consumables, In-vitro diagnostics +3 more | 44 | 1 | 0 | 32.2 | 3/5 |
| 12 | MOTIC CHINA GROUP CO., LTD XIAMEN Fujian | Channel Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 6 | 2 | 0 | 32.0 | 3/5 |
| 13 | YIWU DAQIDA PLASTIC PRODUCTS CO., LTD. Yiwu Zhejiang | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +2 more | 9 | 1 | 0 | 28.5 | 3/5 |
| 14 | ZHEJIANG LANHINE MEDICAL PRODUCTS LTD. Cixi City Zhejiang | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, In-vitro diagnostics +3 more | 9 | 1 | 0 | 28.5 | 3/5 |
| 15 | LISENLU (GUANGZHOU) HEALTH TECHNOLOGY CO., LTD Guangzhou, Guangdong | Channel Distributor, Registration holder, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology | 3 | 4 | 0 | 28.1 | 3/5 |
| 16 | SHANGHAI ZJ BIO-TECH CO., LTD. SHANGHAI | Channel Distributor, Manufacturer, Exporter | In-vitro diagnostics | 3 | 1 | 0 | 23.8 | 3/5 |
| 17 | YANTAI BAGMART PACKAGING CO LTD Yantai Shandong | Channel Distributor, Manufacturer, Exporter | General hospital and consumables, In-vitro diagnostics | 3 | 1 | 0 | 23.8 | 3/5 |
| 18 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. SHENZHEN Guangdong | Holder Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +7 more | 869 | 71 | 0 | 71.4 | 3/5 |
| 19 | ASSURE TECH. (HANGZHOU) CO., LTD. Hangzhou Zhejiang | Holder Registration holder, Manufacturer | Ear, nose and throat, In-vitro diagnostics | 253 | 125 | 0 | 66.2 | 3/5 |
| 20 | HANGZHOU ALLTEST BIOTECH CO., LTD. Hangzhou Zhejiang | Holder Registration holder, Manufacturer | Ear, nose and throat, In-vitro diagnostics | 172 | 128 | 0 | 64.3 | 3/5 |
Questions about in-vitro diagnostics distributors in China
How many in-vitro diagnostics distributors are there in China?
The Index counts 546 establishments in China with in-vitro diagnostics in their registry record, of which 17 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics device registration in China?
In China the NMPA registration certificate is issued in the overseas manufacturer's name, but a legal agent based in China is mandatory and import goes through licensed operators holding a medical device business licence. The agent appointment, not the distribution agreement, controls the registration.
How do I find a in-vitro diagnostics distributor in China?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and China to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a in-vitro diagnostics distributor in China?
A company that appears in a public regulatory registry with an address in China and whose linked device listings fall in the in-vitro diagnostics segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in China
In-vitro diagnostics in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 539 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 60 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.