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How does the Catalogue of Industries for Guiding Foreign Investment regulate the Medical Device Industry in China?
Q&AThe Catalogue is the framework document for setting restrictions/ prohibitions on foreign investment into certain industries in China, and is jointly issued by the National Development and Reform Commission and Ministry of Commerce. Regarding the medical device industry specifically, the revised version of the Catalogue from 2011 removed previous restrictions on the manufacture of non disposable syringes, infusion sets, blood transfusion devices and blood bags -giving foreign investors access to the manufacture and distribution of all types of medical devices in China.
The Catalogue also includes several types of high-end devices under the category of industries “encouraged” for foreign investment, including electronic endoscopes, fundus cameras, key components of medical imaging equipment, (3D) ultrasonic transducers for medical use, equipment for boron neutron capture therapy (BNCT), image-guided intensity modulated radiation therapy systems, hemodialysis machines and hemofiltration machines, as well as equipment for fully automated enzyme immunoassay (EIA) systems. Most recently, further revisions to the Catalogue were released on Nov. 4, 2014 in the form of an opinion-seeking draft (the deadline for public commentary is Dec. 3, 2014). In its current draft, the revised Catalogue newly includes several types of devices under the Encouraged category, namely, blood cells analyzers, automatic chemiluminescence immune analyzers, and high throughput sequencing systems."
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