The last issue of Nanotechnology Law & Business had an interesting article on nanotechnology regulation and patent issues in China:  D. Liu, Nanotechnology in China: Regulations and Patents, Nanotechnology Law & Business, (Winter 2008).  The author is a Lecturer in Law at Newcastle Law School in the U.K.  For Nanolawreport readers, the article contains useful information regarding commercial applications, research and development, environmental health and safety, and regulation of nanoscale materials in China.

Commercial Applications

Professor Liu notes that the OECD "reports that about 1,000 enterprises presently engage in nanotechnology in China. . . . Nanoproducts consist mainly of ‘nanoscale powders of oxides, metals, carbon nanotubes, fullerenes, their diverse derivatives, and applications of them such as those for coatings, fibers, fabric, papers, ceramics, catalysts, and nanomedicine, etc.’ "

"[N]anoscience and nanotechnology are one of the four major fields of science research in China’s medium and long-term plans for development. In the 2001-05 period, China invested U.S.$400 million in nanotechnology. In 2005, China’s investment in nanotech research was U.S.$250 million, second only to investment in the U.S. In 2006, the amount was U.S.$160 million.

Environment, Health, and Safety

"During the period of 2003-2006, 10% of the [Chinese government’s] investment in nanotechnology [was] allocated [to environmental, health, and safety research].  The National Center for Nanoscience and Technology (‘NCNST’), affiliated with the Chinese Academy of Sciences (‘CAS’) engages research on bio-safety such as cellular toxic effects of artificial nano-materials as mass produced in China. Toxicology studies on nanomaterials intended for medicines are being conducted by CAS, Beijing University and the Chinese Academy of Medical Sciences and other institutions." 


"In 2004, the National Bureau of the State Food and Drug Administration (‘SFDA’) issued a regulation classifying ‘nanometer silver antibiotic device for women’s use. . . as a Class II medical device.’   It is said that ‘[c]urrently, there are some 10 products made with nanometer level metal materials that have been registered and sold in the market as Class II medical devices.’  Then, SFDA issued a new regulation in 2006 to replace the previous regulation.  Under the new regulations, ‘medical devices made with nanometer biological materials (for example medical instruments made with nanometer metal silver material) will be classified as Class III medical devices, and be subject to the administration of the relevant regulations of Class III medical devices.’ ”




Research and Development