Medical device companies will be allowed to sell online in China

The market size of medical devices is ca. 36b Euro in China in 2014, among which 2,25b Euro were sold online. However, medical devices could only be sold through licensed online pharmacies, because online medical device stores are prohibited in China so far. Hence many Chinese medical device marketers acquire online pharmacies in order to walk around the hurdle. 

Things will change in 2015, CFDA will issue licenses to qualified medical device marketers, to enable them to open online stores aiming at medical devices. Device makers and marketers are inspired by the new policy, who predict strong uplift of sales achievement in the coming years.

2014 Q1 Export & Import of Artificial Joints by China

In Q1 2014, Chinese manufacturers exported artificial joints to EU valuing $20,4 million, which represents 91,06% of total export of artificial joints. EU is the largest buyer of artificial joints produced in China.


There are 22 artificial joint manufacturers in China, located in Jiangsu, Beijing, Shanghai, Shaanxi, Tianjin, Hebei, Fujian and Henan. Belgium is the Nr. 1 target market, who imported $16 million from China. While the YOY export to Germany increased 147.16%.

At the mean time China is also an importer of artificial joints, who imported total value of $36 million of artificial joints from EU in Q1 2014, $35,7 million from USA.

Polymer Material Medical Devices Demand Increased in China

The size of Chinese medical device market is expected to reach 340 billion RMB by 2015, moving at a speed of an average yearly compound increasing rate of 23%.

Among tens of thousands of medical devices available in the market, demand to those devices made from polymer material keeps expanding year after year. The polymer material devices designed and manufactured to be small in size, implantable and multipurpose are estimated to be having a yearly increasing rate of 6% until 2018.

Shanghai Customs Region Imported RMB4.6b Medical Equipment in Q1 2014

In Q1 2014, Shanghai customs region imported medical devices and equipment valuing RMB 4.62 billion, resulting in an increase of 7,8% on YoY basis. Among the total import, RMB 1,7 billion was imported from USA (+6,1%), RMB 1,3 billion from EU (-6,2%), and RMB 0,7 billion from Japan (+6%). Import from USA, EU and Japan represents 81% of total import.

In Chinese hospitals, 100% of artificial hip or knee joints, 100% of pace makers and 90% of CT machines are imported. In Q1 2014, around RMB 0,56 billion of endoscopes were imported to Shanghai customs Region.

CFDA Exempted 140 Class II Devices from Clinical Trial

China Food and Drug Administration (CFDA) issued notice exempting 140 Class II medical devices from submitting clinical trial when device producers apply for market entry from CFDA. This is already the second batch of clinical trial exemption.

For a Class II device maker outside China, perhaps JV with a local Chinese producer is one the best options if one looks for a long term reward in the Chinese market, depending on the nature of the product itself.